Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?
PLUS
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedSeptember 27, 2019
September 1, 2019
5.7 years
January 8, 2014
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
We evaluate the pregnancy, at 7 weeks amenorrhoea. Outcome is clinical pregnancy rate
7 weeks
Secondary Outcomes (1)
number of monitoring visits at the clinic per cycle
7 weeks
Study Arms (2)
A: spontaneous LH peak
PLACEBO COMPARATORIn group A, embryos are thawed 4 days after LH surge, with a re-evaluation and transfer 5 days after LH surge.
B: hCG
ACTIVE COMPARATORIn group B, embryos are thawed 5 days after hCG administration, with a re-evaluation and transfer 6 days after hCG.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre of Reproductive Medicine CRG
Jette, Brussels Capital, 1090, Belgium
Related Publications (1)
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.
PMID: 32395750DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 8, 2014
First Posted
May 23, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
September 27, 2019
Record last verified: 2019-09