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

in Vitro Fertilization Clinical Trial

— TECNAT  

Official title:

Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428165
• Other study ID #: NIMAO/2017-02/SH-01
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 1, 2022
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• in Vitro Fertilization

Intervention

Other:
• HCG
250 µg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono

Locations

Country	Name	City	State
France	CHU Arnaud de Villeneuve	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate after transfer of frozen embryos at day 14 between groups	Yes/no; Blood ßHCG > 100UI/L	Day 14
Secondary	Pregnancy rate at week 12	Yes/no; ultrasound	Week 12
Secondary	Miscarriage rate within first 12 weeks	Yes/no; ultrasound	Week 12
Secondary	Live birth	Yes/no	At delivery, maximum week 42
Secondary	Pregnancy term	Weeks	At delivery, maximum week 42
Secondary	Birth weight	Kg	At delivery, maximum week 42
Secondary	Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)	Yes/no	Day 0
Secondary	Number of visits for endometrial preparation until attaining LH peak	Number of visits	Day 0