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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT03428165
Collaborator
(none)
103
Enrollment
2
Locations
2
Arms
46.9
Actual Duration (Months)
51.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HCG
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Mar 7, 2018
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: human chorionic gonadotropin (HCG)

Ovulation triggered using HCG: choriogonadotropin alpha (Ovitrelle, Merck Serono), 250 μg/0.5ml

Other: HCG
250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono
No Intervention: spontaneous

Outcome Measures

Primary Outcome Measures

  1. Pregnancy rate after transfer of frozen embryos at day 14 between groups [Day 14]

    Yes/no; Blood ßHCG > 100UI/L

Secondary Outcome Measures

  1. Pregnancy rate at week 12 [Week 12]

    Yes/no; ultrasound

  2. Miscarriage rate within first 12 weeks [Week 12]

    Yes/no; ultrasound

  3. Live birth [At delivery, maximum week 42]

    Yes/no

  4. Pregnancy term [At delivery, maximum week 42]

    Weeks

  5. Birth weight [At delivery, maximum week 42]

    Kg

  6. Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level) [Day 0]

    Yes/no

  7. Number of visits for endometrial preparation until attaining LH peak [Day 0]

    Number of visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Arnaud de Villeneuve Montpellier France 34295
2 CHU Nimes Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Stéphanie Huberlant, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT03428165
Other Study ID Numbers:
  • NIMAO/2017-02/SH-01
First Posted:
Feb 9, 2018
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 3, 2022