NCT07457684

Brief Summary

The goal of this retrospective study is to compare the effectiveness and cost-effectiveness of two mixed ovarian stimulation protocols in women undergoing in vitro fertilization (IVF). The main questions it aims to answer are:

  • Does the combination of follitropin delta + HP-hMG result in a higher number of utilizable blastocysts per treatment cycle compared to follitropin alfa + HP-hMG?
  • Does the follitropin delta based mixed protocol reduce total gonadotropin dose and cost per usable blastocyst while maintaining or improving pregnancy outcomes? Researchers will compare follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) with follitropin delta (Rekovelle®) + HP-hMG (Menopur®) to determine which protocol improves ovarian response, embryology outcomes, pregnancy rates, and overall treatment cost-efficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
846

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 5, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

10 days

First QC Date

February 24, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

follitropin deltafollitropin alfamenotropinsIVF

Outcome Measures

Primary Outcomes (1)

  • Number of utilizable blastocysts per treatment cycle

    For IVF performed from January 2018 to December 2024

Secondary Outcomes (9)

  • Number of stimulation days

    For IVF performed from January 2018 to December 2024

  • Totals doses of rFSH, HP-hMG, and FSH

    For IVF performed from January 2018 to December 2024

  • Costs of rFSH, HP-hMG, and FSH

    For IVF performed from January 2018 to December 2024

  • Number of retrieved oocytes

    For IVF performed from January 2018 to December 2024

  • Number of mature oocytes (MII)

    For IVF performed from January 2018 to December 2024

  • +4 more secondary outcomes

Study Arms (2)

Follitropin alfa (Gonal-F®) + HP-hMG (Menopur®)

Follitropin delta (Rekovelle®) + HP-hMG (Menopur®)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women who underwent their first IVF cycle between 2018 and 2024 at the ovo clinic

You may qualify if:

  • Women between 18-45 years included
  • First ovarian stimulation cycle only
  • Patients who used mixed protocols combining menotropin and follitropin alfa or delta
  • Patients whose Rekovelle doses were prescribed using the algorithm based on AMH and weight.

You may not qualify if:

  • Patients who did not follow the algorithm to determine follitropin delta dosing and who required dose adjustments during the stimulation
  • Patients who took concomitant treatment, such as corticosteroids, low molecular weight heparin, nonsteroidal anti-inflammatory drugs, recombinant LH or intra-vaginal vasodilators
  • Oocytes donation or fertility preservation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Study Officials

  • Isaac-Jacques Kadoch, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 9, 2026

Study Start

December 5, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations