Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02145819
Acronym
PLUS
Enrollment
240
Registered
2014-05-23
Start date
2014-01-31
Completion date
2019-09-30
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supervision of Pregnancy Resulting From In-vitro Fertilization

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.

Interventions

DRUGhCG
OTHERLH peak

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
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

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate7 weeksWe evaluate the pregnancy, at 7 weeks amenorrhoea. Outcome is clinical pregnancy rate

Secondary

MeasureTime frame
number of monitoring visits at the clinic per cycle7 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026