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Luteal-phase support in assisted reproduction treatment: real-life practices reported worldwide by an updated website-based survey

Reproductive BioMedicine Online, Volume 28, Issue 3 , Pages 330-335, March 2014

Abstract

An updated worldwide web-based survey assessed the real-life clinical practices regarding luteal-phase supplementation (LPS) in assisted reproduction. This survey looked for changes since a former survey conducted nearly 3 years earlier. The survey questions were: If you support the luteal phase, when do you start the regimen you are using?; Which agent/route is your treatment of choice to support the luteal phase?; If you use vaginal progesterone, which formulation do you use?; and How long you continue progesterone supplementation if the patient conceived? Data were obtained from 408 centres (82 countries) representing 284,600 IVF cycles/year. The findings were: (i) most practitioners (80% of cycles) start LPS on the day of egg collection; (ii) in >90%, a vaginal progesterone product is used (77% as a single agent and 17% in combination with i.m. progesterone), while human chorionic gonadotrophin as a single agent for LPS is not being used at all; and (iii) in 72% of cycles, LPS is administered until 8–10 weeks’ gestation or beyond. When compared with the initial survey, the results of this survey are encouraging as there is a clear shift towards a more unified and evidence-based approach to LPS in IVF cycles.

This updated worldwide web-based survey assessed the actual real-life clinical practices regarding luteal-phase supplementation (LPS) in assisted reproduction. Specifically, this survey looked for changes since an initial survey conducted nearly 3 years earlier. The survey included the following questions: If you support the luteal phase, when do you start the regimen you are using?; Which agent/route is your treatment of choice to support the luteal phase?; If you use vaginal progesterone, which formulation do you use?; and How long you continue progesterone supplementation if the patient conceived? Data from 408 centres in 82 countries representing a total of 284,600 IVF cycles/year were included. Most practitioners (80% of cycles) start LPS on the day of egg collection and in more than 90% a vaginal progesterone product is used for LPS (in 77% as a single agent and in 17% in combination with i.m. progesterone). As a single agent for LPS, human chorionic gonadotrophin is not being used at all. Regarding the duration of supplementation, in 72% of cycles, LPS is administered until 8–10 weeks’ gestation or beyond. When compared with the initial survey from 2009, the results of this updated survey are encouraging as there is a clear shift towards a more unified and evidence-based approach to luteal-phase support in IVF cycles. Nevertheless, although there is no firm evidence supporting the continuation of LPS after the demonstration of fetal heart beat on ultrasound, this remains the common practice of the majority of assisted reproduction centres worldwide.

Keywords: ART, human chorionic gonadotrophin, IVF, luteal phase, LPS, progesterone.

Introduction

It is well established that the ovarian stimulation regimens used in virtually all assisted reproduction cycles alter the luteal phase (Edwards et al, 1980, Kolibianakis et al, 2003, Macklon and Fauser, 2000, and Ubaldi et al, 1997). Ovarian stimulation ultimately causes an inadequate development of the endometrium and an asynchrony between the endometrium and the transferred embryos, resulting in adverse effects on endometrial receptivity (Abate et al, 1999, Devroey et al, 2004, Kolibianakis et al, 2002, Macklon and Fauser, 2000, Nikas et al, 1999, and Smitz et al, 1988). In more than 50% of the cases, ovarian stimulation delays endometrial development by 2 or more days, which hampers the implantation chances ( de Ziegler et al., 1994 ).

The first meta-analysis on luteal-phase supplementation (LPS) nearly 20 years ago concluded that both human chorionic gonadotrophin (HCG) or progesterone supplementation improve pregnancy rates ( Soliman et al., 1994 ). Since then, several other meta-analyses and Cochrane reviews have confirmed and expanded these early results (Daya and Gunby, 2004, Nosarka et al, 2005, and Pritts and Atwood, 2002). Recently, Van der Linden et al. (2011) published an updated Cochrane Review of 69 studies totaling 16,327 women, which confirmed the beneficial effects of LPS using exogenous progesterone. In this review, the addition of other agents such as oestrogen or HCG did not seem to improve outcome.

IVF-Worldwide ( www.IVF-Worldwide.com ) is a comprehensive IVF-focused website for doctors, embryologists, nurses and social workers. The primary aim of IVF-Worldwide is to offer to its members the possibility to locate IVF programmes anywhere in the world and communicate directly with their members. The website, which brings together doctors and assisted reproduction specialists from around the world, promotes dialogue and discussions on all sorts of treatment and management issues. The website is a non-commercial entity supervised by an advisory board of 52 key leaders in the field. It regularly reviews questions of general interest in assisted reproduction treatment, such as those on LPS as reported here.

Studies reporting on LPS and the meta-analyses that sum up their findings rely on data obtained in the women who partook in the published studies. Generally these women have to satisfy sometimes-stringent exclusion and exclusion criteria,de factomaking them subgroups of the general population. This explains that lingering questions remain as to whether the results of the classic studies are always relevant for the everyday life problems encountered by assisted reproduction specialists around the world. In order to address these issues, IVF-Worldwide conducted a first web-based survey on LPS in assisted reproduction and posted its results on the website of IVF-Worldwide.com in 2009 ( Vaisbuch et al., 2012 ). Strikingly, the survey revealed that doctors generally failed to abide by the rules of evidence-based medicine in their everyday medical practices. Indeed, nearly two-thirds of programmes reported that vaginally administered progesterone was the preferred form of LPS. Yet, in apparent contradiction with the above, oral progesterone, i.m. progesterone and HCG were still routinely used by many practitioners for LPS despite published data highlighting their disadvantages. The present work reports an update of the original web-based survey, posted on www.IVF-Worldwide.com . The new data were mustered for assessing whether LPS practices in assisted reproduction had changed since the initial survey conducted nearly 3 years ago.

Materials and methods

The web-based questionnaire entitled ‘An updated survey on the use of progesterone for luteal-phase support in stimulated IVF cycles’ was posted on the IVF-Worldwide website on 24 May 2012 and remained open for entering data until 26 June 2012. The survey contained demographic questions including the name of the unit’s medical director, the name of the IVF unit, email address, country and number of IVF cycles in the unit in the most recent year.

The specific questions addressed progesterone support in IVF and included: (i) If luteal-phase support is offered, when is your regimen started? The survey offered four possible answers for this question: (a) day of egg collection; (b) day of embryo transfer; (c) day of HCG administration; and (d) a few days after embryo transfer; (ii) Which agent/route is your treatment of choice for luteal-phase support? The offered answers were: (a) vaginal progesterone; (b) i.m. progesterone; (c) oral progesterone; (d) combination of the drugs mentioned above; (e) HCG; and (f) other; (iii) If you use vaginal progesterone, which formulation do you use? The offered answers were: (a) vaginal tablets; (b) vaginal progesterone gel; (c) vaginal suppositories; and (d) combination of the above; and (iv) How long do you continue progesterone supplementation when the patient conceives? The offered answers were: (a) until pregnancy is confirmed in a blood or urine test; (b) until the presence of fetal heart beat; (c) until gestational weeks 8–10; and (d) until gestational week 12 or later.

Quality assurance methods

In order to minimize duplicate reports from a unit and possible false data, quality assurance methods were used as previously described ( Vaisbuch et al., 2012 ). In brief, the consistency of four parameters in the self-reported data of the unit surveyed with existing data of units registered on the IVF-Worldwide website was assessed using a computerize software. These parameters included the name of the unit, the name of the unit director, country and email address. If at least three of these parameters from the survey matched the website archive data, this reporting site’s data was included in the statistical analyses.

Statistical analysis

The analysis was based on the number of IVF cycles reported by the unit and not on the number of units in the study. For each question, the survey provided multiple choices from which only a single answer could be chosen (‘radio buttons’). For example, for a question with four answers (a, b, c, d), the following results were calculated:

FORMULA:

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Results

Between 24 May and 26 June 2012, 481 IVF units from 82 countries responded to the solicitation of making an updated survey. Table 1 displays the distribution of the 408 IVF units that passed the computerized system’s quality assurance test and the total number of cycles/year by continent. The average number of IVF treatment cycles per participating centre was approximately 700 cycles/year. Figure 1 shows the distribution of units according to the total IVF cycles treated per year. Forty-two IVF units reported between 1000 and 2000 cycles, 14 units reported between 2001 and 4000 cycles and eight IVF units treated more than 4000 cycles per year. In total, this report analysed 284,600 IVF cycles/year ( Table 2 ).

Table 1 Total number of IVF units and cycles/year by continent.

Continent No. of cycles No. of units
USA and Canada 26,200 52
Central and South America 13,300 46
Australia and New Zealand 17,900 14
Asia 63,300 89
Europe 150,700 185
Africa 13,200 22
 
Total 284,600 408
gr1

Figure 1 Distribution of IVF units according to the total number of cycles treated per year.

Table 2 Comparison of the initial survey in 2009 with the current survey.

  Current survey (June 2012) Previous survey (September 2009)
Cycles per year 284,600 51,155
Vaginal progesterone only 77 64
i.m. progesterone only 5 13
Oral progesterone only 0.5 2
Combined drugs 17 16
HCG only 0 5
Duration of LPS beyond 8 weeks of gestation 72 a 67 b

a Until 8–10 weeks of gestation (44%) or up to 12 weeks or more (28%).

b Until 10–12 weeks of gestation.

Values arenor%.

HCG = human chorionic gonadotrophin; LPS = luteal-phase supplementation.

If luteal-phase support is offered, when is your regimen started?

In 80.1% of the treated cycles, progesterone was started on the day of egg collection. LPS was initiated on the day of embryo transfer in 15.4% of cycles, while only a minority supported the luteal phase starting on the day of HCG administration (3.2%) or a few days after embryo transfer (1.3%).

Which agent/route is your treatment of choice for luteal-phase support?

In more than three-quarters (77%) of the reported cycles, vaginal progesterone was used alone for LPS. In another 17.3% of cycles, vaginal progesterone was combined with i.m. or oral progesterone. Intramuscular progesterone was used alone in 4.6% of cycles and oral progesterone in only 0.5% of cycles. HCG was not used as a single agent for LPS according the website-based survey ( Table 2 ).

If you use vaginal progesterone, which formulation do you use?

The most commonly used vaginal progesterone preparation was a vaginal tablet, preferred in 46% of cycles. A vaginal gel was used in 25% of cycles, while suppositories were opted for in 14%. In 15%, a combination of different vaginal preparations was reported.

How long do you continue progesterone supplementation when the patient conceives?

In 15% of the cycles, LPS was administered until pregnancy was confirmed by a positive βHCG test and discontinued thereafter. In 13%, progesterone was discontinued after the identification of a fetal heart beat on ultrasound. In almost half of cycles (44%), LPS was administered until 8–10 weeks of gestation, and in another 28%, it was prescribed for up to 12 weeks or more.

Discussion

Compared with the earlier website survey of 2009 ( Vaisbuch et al., 2012 ), the present updated survey on the clinical use of progesterone for LPS in assisted reproduction has a larger span. Whereas the 2009 survey included data from 84 treatment centres in 35 countries, the present updated survey is based on reports of 408 treatment centres from 82 countries. Globally, the present data amount to 284,600 treated IVF cycles/year.

The main findings of the updated web-based survey are: (i) most practitioners (80% of cycles) start LPS on the day of egg retrieval; (ii) in more than 90% of the reported cycles, a vaginal progesterone preparation is used for LPS, either alone (77%) or in combination with i.m. progesterone injections (17%), while HCG is not used as a single agent for LPS; and (iii) in more than two-thirds of cycles (72%), luteal-phase support is continued until 8–10 weeks of gestation or beyond.

The current updated survey reveals several major changes in the clinical practice of LPS in assisted reproduction that took place during the 3 years since the previous study ( Vaisbuch et al., 2012 ): (i) HCG, which was used in 5% of cycles in the initial report, is not used anymore for LPS; (ii) the use of i.m. progesterone declined considerably from 13% to 5%; and (iii) there is an increased use of vaginal progesterone preparations. These shifts in the clinical practice of LPS support in assisted reproduction treatment are in agreement with current evidence-based data published in this field. Conversely, no major differences have been noticed between the two surveys regarding the duration of LPS.

Daya and Gunby (2004) , and later van der Linden et al. (2011) in their systematic Cochrane review, concluded that HCG is not superior to progesterone while causing greater risks of ovarian hyperstimulation syndrome. Accordingly, the current updated survey reporting that HCG has been completely abandoned as unique source of LPS indicates that this particular message has been widely received.

Regarding the route of progesterone administration, oral progesterone has been shown to have a low bioavailability (<10%) and has been generally demonstrated to be inferior to the i.m. or the vaginal routes (Bourgain et al, 1990, Devroey et al, 1989, and Ludwig and Diedrich, 2001). Direct comparisons between the i.m. and the vaginal routes have initially demonstrated conflicting results. Recently, however, published data suggest comparable effects between the two routes ( van der Linden et al., 2011 ). Indeed, a meta-analysis by Zarutskie and Phillips (2009) found a comparable effect between the vaginal and i.m. routes of progesterone administration on the endpoints of clinical pregnancy (relative risk 0.91, 95% CI 0.74–1.13) and ongoing pregnancy (relative risk 0.94, 95% CI 0.71–1.26). In their recent Cochrane review, van der Linden et al. (2011) reported no major difference in outcome between different progesterone regimens. Puzzlingly, however, these authors reported higher rates of clinical pregnancy when synthetic progesterone, dydrogesterone, was used for LPS as compared with progesterone (Peto odds ratio 0.79, 95% CI 0.65–0.96). This contrasts with the fact that dydrogesterone failed to induce endometrial decidualization in the donor egg model ( Fatemi et al., 2007 ). Data on oral synthetic progestin reported in the Cochrane meta-analysis need to be verified in clinical conditions closer to common assisted reproduction operations before they can be taken into consideration.

The decrease in the use of i.m. progesterone likely reflects the cumbersomeness of these injections (i.e. not self-administrable) and the possibility of serious local reactions (Costabile et al, 2001 and Lightman et al, 1999). The latter include inflammatory reactions and sterile abscess formation at the injection site ( Propst et al., 2001 ) and even more serious complications such as acute eosinophilic pneumonia (Bouckaert et al, 2004 and Veysman et al, 2006).

Consistent with the arguments laid out above (van der Linden et al, 2011 and Zarutskie and Phillips, 2009), the updated survey reports that vaginal progesterone was used in nearly 95% of the cases. Interestingly, in about 17% of these cycles, an additional route of progesterone administration was also used. A plausible explanation for combining several routes of LPS administration is that certain physicians may fear suboptimal compliance with vaginal progesterone due to personal and/or cultural aversion for this route of treatment.

Concerning the duration of LPS, no major differences have been found between the two surveys, indicating that physicians pursue LPS beyond what appears strictly necessary (Aboulghar et al, 2008, Liu et al, 2012, Ludwig and Diedrich, 2001, Nyboe Andersen et al, 2002, and van der Linden et al, 2011). Indeed, although there is no evidence for continuing beyond the day documenting fetal heart activity, the current updated survey shows that most practitioners abide by these rules, as in over 70% of the cycles LPS continues to be administered until 8–10 weeks of gestation or beyond.

The main strength of this survey is that it gauges clinical practice patterns worldwide and includes not only academic centres but also private practices. As far as is known, this survey is the largest to date assessing the clinical practice of LPS, including data from 481 IVF units worldwide. The website-based survey therefore offers an important perspective on clinical practice on a global scale. However, the methodology of this survey is associated with several potential limitations. First, there is a possible inherent self-selection bias as this survey was posted on a website and not sent directly to the units. Secondly, although efforts to identify multiple reports from the same unit were made, this possibility cannot completely be ruled out. Finally, the entered data represents an estimate of the clinical practice in each unit, rather than objective data.

In conclusion, the updated survey is encouraging as it reveals a clear shift towards a more unified and evidence-based clinical practices regarding LPS in assisted reproduction treatment. The issue of LPS duration still remains to be carefully addressed however. Interestingly, this survey reports a clear and persisting discrepancy between the rising evidence that LPS can be stopped after documenting fetal heart activity (Aboulghar et al, 2008, Liu et al, 2012, and van der Linden et al, 2011) or even on the day of the positive pregnancy test ( Schmidt et al., 2001 ). The data indicate indeed it is the worldwide practice to continue LPS for up 10 weeks of gestation.

Acknowledgements

The authors would like to thank the responders for their participation in this survey.

References

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Footnotes

a Department of Obstetrics and Gynecology, Kaplan Medical Center (Affiliated with the Hebrew University of Jerusalem and Hadassah School of Medicine, Jerusalem, Israel), Rehovot, Israel

b Division Reprod. Endocr. and Infertility, Université Paris Descartes–Hôp. Cochin, Paris, France

c IVF Centre, the Hong Kong Sanatorium and Hospital, Happy Valley, Hong Kong

d IVF Unit, Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel

lowast Corresponding author.

fx1 Edi Vaisbuch obtained his medical degree at the Hebrew University and Hadassah School of Medicine in Jerusalem and completed his residency at the Kaplan Medical Centre, Israel. In 2007 he joined the Perinatology Research Branch of NICHD/NIH/DHHS in Detroit as a research associate and in 2008 was appointed as an Assistant Professor at the Wayne State University in Detroit, Michigan. Currently, he is in charge of the high-risk pregnancy unit at Kaplan Medical Centre. His special interest is in complications of pregnancy and pregnancy outcomes and he is an author and co-author of more than 90 peer-reviewed publications.