Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate

Not Applicable

Completed

• Conditions: in Vitro Fertilization
• Interventions: Other: HCG

• Registration Number: NCT03428165
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-09
• Study Start: 2018-03-07
• Primary Completion: 2021-06-29
• Study Completion: 2022-02-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is aged between 18 and 40
• Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)

Exclusion Criteria

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Patient using donated oocytes
• Necessity of pre-implantation diagnosis
• Patients with stage 3 or 4 endometriosis or adenomyosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
human chorionic gonadotropin (HCG)	HCG	Ovulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml

Primary Outcome Measures

Name	Time	Method
Pregnancy rate after transfer of frozen embryos at day 14 between groups	Day 14	Yes/no; Blood ßHCG \> 100UI/L

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate at week 12	Week 12	Yes/no; ultrasound
Miscarriage rate within first 12 weeks	Week 12	Yes/no; ultrasound
Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)	Day 0	Yes/no
Number of visits for endometrial preparation until attaining LH peak	Day 0	Number of visits
Pregnancy term	At delivery, maximum week 42	Weeks
Birth weight	At delivery, maximum week 42	Kg
Live birth	At delivery, maximum week 42	Yes/no

Trial Locations

Locations (2)

CHU Nimes; 🇫🇷 Nîmes, France

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, France