NCT03428165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

December 4, 2025

Status Verified

June 1, 2022

Enrollment Period

3.3 years

First QC Date

February 5, 2018

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate after transfer of frozen embryos at day 14 between groups

    Yes/no; Blood ßHCG \> 100UI/L

    Day 14

Secondary Outcomes (7)

  • Pregnancy rate at week 12

    Week 12

  • Miscarriage rate within first 12 weeks

    Week 12

  • Live birth

    At delivery, maximum week 42

  • Pregnancy term

    At delivery, maximum week 42

  • Birth weight

    At delivery, maximum week 42

  • +2 more secondary outcomes

Study Arms (2)

human chorionic gonadotropin (HCG)

OTHER

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

Other: HCG

spontaneous

NO INTERVENTION

Interventions

HCGOTHER

250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono

human chorionic gonadotropin (HCG)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Ranisavljevic N, Bonneau M, Rougier N, Hamamah S, Anahory T, Serand C, Huberlant S. Ovulation trigger versus spontaneous luteinizing hormone surge on live birth rate after frozen embryo transfer in a natural cycle: a randomized controlled trial. Fertil Steril. 2025 Apr;123(4):718-720. doi: 10.1016/j.fertnstert.2024.10.021. Epub 2024 Oct 19. No abstract available.

Study Officials

  • Stéphanie Huberlant

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 9, 2018

Study Start

March 7, 2018

Primary Completion

June 29, 2021

Study Completion

February 1, 2022

Last Updated

December 4, 2025

Record last verified: 2022-06

Locations