Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- clinical pregnancy rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
A: spontaneous LH peak
In group A, embryos are thawed 4 days after LH surge, with a re-evaluation and transfer 5 days after LH surge.
Intervention: LH peak (Other)
B: hCG
In group B, embryos are thawed 5 days after hCG administration, with a re-evaluation and transfer 6 days after hCG.
Intervention: hCG (Drug)
Outcomes
Primary Outcomes
clinical pregnancy rate
Time Frame: 7 weeks
We evaluate the pregnancy, at 7 weeks amenorrhoea. Outcome is clinical pregnancy rate
Secondary Outcomes
- number of monitoring visits at the clinic per cycle(7 weeks)
Investigators
Arne van de Vijver
Medical Doctor
Universitair Ziekenhuis Brussel