Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?

NCT ID: NCT02145819

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-09-30

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.

Conditions

Supervision of Pregnancy Resulting From In-vitro Fertilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

LH peak

Intervention Type: OTHER

B: hCG

In group B, embryos are thawed 5 days after hCG administration, with a re-evaluation and transfer 6 days after hCG.

Group Type: ACTIVE_COMPARATOR

hCG

Intervention Type: DRUG

Interventions

hCG

Intervention Type: DRUG

LH peak

Intervention Type: OTHER

Other Intervention Names

spontaneous LH peak

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Arne van de Vijver

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre of Reproductive Medicine CRG

Jette, Brussels Capital, Belgium

Countries

Belgium

References

Mackens S, Stubbe A, Santos-Ribeiro S, Van Landuyt L, Racca A, Roelens C, Camus M, De Vos M, van de Vijver A, Tournaye H, Blockeel C. To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial. Hum Reprod. 2020 May 1;35(5):1073-1081. doi: 10.1093/humrep/deaa026.

Reference Type: DERIVED

PMID: 32395750 (View on PubMed)

Other Identifiers

PLUS

Identifier Type: -

Identifier Source: org_study_id