Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?
- Conditions
- Supervision of Pregnancy Resulting From In-vitro Fertilization
- Interventions
- Other: LH peak
- Registration Number
- NCT02145819
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
The aim of the study is to determine whether spontaneous LH peak is superior to human chorionic gonadotropin before a transfer of a day 3 frozen embryo.
- Detailed Description
For surplus embryos after fresh IVF-cycles, cryopreservation has become common medical practice. These frozen embryos are mostly replaced in an artificial cycle with exogenous estrogen and progesterone or in a natural cycle. Often, hCG is administered as an ovulation induction agent for scheduling purposes.
Successful implantation requires a co-ordinated series of events allowing a timely dialogue between a receptive endometrium and the intrusive blastocyst . The period of receptivity is thought to be 3 days in human. It is suggested that blastocyst apposition begins about day LH+6 and is completed by day LH+10
In general, the aim is to transfer the embryo during the 'window of implantation', what is defined as the period during which the uterus is receptive for implantation of the free-lying blastocyst. This has been a subject of debate since many years.
A prospective study by Fatemi et al. (2010) revealed a significantly higher ongoing pregnancy rate after transferring frozen-thawed embryos in natural cycles with a spontaneous LH peak compared with natural cycles controlled by hCG for final oocyte maturation and ovulation (31.1% vs. 14.3%, respectively). In this trial, FrET (frozen embryo transfer) was planned 5 days after the LH surge or 5 days after the administration of 5000IU of hCG.
In order to optimize the synchronization in the hCG group, and therefore enhance the pregnancy rates, the aim is to plan a FrET 6 days after hCG administration instead of 5 days. The rationale behind is that day 3 frozen embryos are thawed the day before embryo transfer, which means they are already at day 4 of the embryonic development.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- Natural cycles, in which a frozen-thawed day 3 embryo is replaced.
- Signed informed consent.
- Regular cycle (i.e. between 26 and 35 days)
- Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa.
- Embryos frozen by vitrification.
- Single or dual embryo transfer.
- Known allergic reactions to progesterone products.
- Intake of experimental drug within 30 days prior to study start.
- Contraindication for pregnancy.
- Embryos of women above 39 years of age at the time of embryo freezing.
- Recipients of oocyte donation cycles
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A: spontaneous LH peak LH peak In group A, embryos are thawed 4 days after LH surge, with a re-evaluation and transfer 5 days after LH surge. B: hCG hCG In group B, embryos are thawed 5 days after hCG administration, with a re-evaluation and transfer 6 days after hCG.
- Primary Outcome Measures
Name Time Method clinical pregnancy rate 7 weeks We evaluate the pregnancy, at 7 weeks amenorrhoea. Outcome is clinical pregnancy rate
- Secondary Outcome Measures
Name Time Method number of monitoring visits at the clinic per cycle 7 weeks
Trial Locations
- Locations (1)
Centre of Reproductive Medicine CRG
🇧🇪Jette, Brussels, Belgium