Late-Start Corifollitropin Alfa in Mild Ovarian Stimulation

NCT07891793 | Completed

• 1 other identifier: 0101241811
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical study evaluates a novel physiology-oriented mild ovarian stimulation protocol based on the delayed initiation of corifollitropin alfa. Unlike conventional ovarian stimulation, which begins during the early follicular phase, the proposed protocol postpones exogenous gonadotropin administration until cycle day 4, allowing physiological follicular recruitment to occur before ovarian stimulation. Participants are randomly assigned to one of two strategies for prevention of premature luteinizing hormone (LH) surge: daily GnRH antagonist administration, or progesterone-primed ovarian stimulation (PPOS). The primary objective is to evaluate ovarian response and the feasibility of this simplified stimulation strategy. Secondary objectives include embryological outcomes, pregnancy outcomes, gonadotropin consumption, treatment burden, and the proportion of patients completing stimulation without supplementary gonadotropin administration. The study aims to determine whether a physiology-oriented late-start stimulation protocol can simplify IVF treatment while maintaining satisfactory embryological and clinical outcomes.

Conditions

Infertile Patient Undergoing ICSI Procedure

Outcome Measures

Primary Outcomes (1)

• Number of Mature (MII) Oocytes Retrieved per Initiated Stimulation Cycle

  The number of mature metaphase II (MII) oocytes obtained following ovarian stimulation, assessed at the time of oocyte retrieval. The outcome will be expressed as the number of MII oocytes per initiated stimulation cycle. Participants whose cycles are cancelled before oocyte retrieval or who have no mature oocytes retrieved will be assigned a value of zero.

  From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.

Secondary Outcomes (12)

• Total Number of Oocytes Retrieved per Initiated Stimulation Cycle

  From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.

• Oocyte maturation rate

  At oocyte retrieval, up to 14 days after initiation of ovarian stimulation.

• Normal fertilization rate (2PN)

  At fertilization assessment, 1 day after ICSI.

• Blastocyst formation rate

  From fertilization through day 6 of embryo culture.

• Number of Usable Blastocysts per Oocyte Retrieval

  From fertilization through day 6 of embryo culture.

Study Arms (2)

Late-Start Corifollitropin Alfa + GnRH Antagonist

ACTIVE COMPARATOR

Participants receive oral placebo-free treatment according to the study protocol. On the evening of cycle day 4, a single subcutaneous injection of 150 μg corifollitropin alfa (Elonva®) is administered as part of a late-start mild ovarian stimulation protocol. Premature luteinizing hormone (LH) surge is prevented using daily administration of a GnRH antagonist. Hormonal monitoring and transvaginal ultrasound are performed on cycle day 7.Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol.Ovulation is triggered with 250 μg recombinant hCG (Ovitrelle®) when at least three follicles reach a mean diameter of 19-20 mm.

Drug: Corifollitropin Alfa 150 μg; Drug: GnRH antagonist; Drug: Human Menopausal Gonadotropin (hMG)

Late-Start Corifollitropin Alfa + Progesterone

EXPERIMENTAL

Participants receive a single subcutaneous injection of corifollitropin alfa 150 μg on the evening of cycle day 4. Premature LH surge is prevented using daily oral progesterone as part of a progesterone-primed ovarian stimulation protocol. Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol.

Drug: Corifollitropin Alfa 150 μg; Drug: Progesterone; Drug: Human Menopausal Gonadotropin (hMG)

Interventions

Corifollitropin Alfa 150 μg DRUG

A single subcutaneous injection of 150 μg corifollitropin alfa administered on the evening of cycle day 4 as part of a late-start mild ovarian stimulation protocol.

Also known as: Elonva 150μg

Late-Start Corifollitropin Alfa + GnRH Antagonist; Late-Start Corifollitropin Alfa + Progesterone

GnRH antagonist DRUG

Daily GnRH antagonist administration for prevention of premature LH surge according to the study protocol.

Late-Start Corifollitropin Alfa + GnRH Antagonist

Progesterone DRUG

Oral micronized progesterone is administered daily as part of progesterone-primed ovarian stimulation for the prevention of a premature LH surge. Treatment is continued until ovulation triggering according to the predefined study protocol.

Late-Start Corifollitropin Alfa + Progesterone

Human Menopausal Gonadotropin (hMG) DRUG

Additional hMG (150 IU/day) administered only when predefined clinical criteria are met according to the study protocol.

Late-Start Corifollitropin Alfa + GnRH Antagonist; Late-Start Corifollitropin Alfa + Progesterone

Eligibility Criteria

• Age: 28 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 28 to 43 years at the time of enrollment.
• Clinical diagnosis of infertility requiring IVF or ICSI treatment.
• Planned controlled ovarian stimulation according to the study protocol.
• Anti-Müllerian hormone concentration of 0.2 ng/mL or greater.
• Presence of both ovaries.
• Ability to provide written informed consent.
• Willingness to comply with all study procedures and follow-up assessments.

You may not qualify if:

• Age younger than 28 years or older than 43 years.
• Anti-Müllerian hormone concentration below 0.2 ng/mL.
• Untreated endocrine disorders that may interfere with ovarian stimulation, including uncontrolled thyroid disease or hyperprolactinemia.
• Contraindication to ovarian stimulation, pregnancy, or transvaginal oocyte retrieval.
• Severe systemic disease considered by the investigator to make participation unsafe.
• Concurrent participation in another interventional clinical study that could interfere with the study outcomes.
• Refusal or inability to provide written informed consent.
• Previous enrollment in this study.

Sponsors & Collaborators

• Assisting Nature: lead

Study Sites (1)

Assisting Nature Fertility Clinic

Thessaloniki, Greece

Location

MeSH Terms

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; Progesterone; Menotropins

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Robert Najdecki, PhD

  Assisting Nature Fertility and Genetics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and treating physicians are aware of the assigned intervention because the two study groups use different methods of LH surge suppression. No masking procedures are applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: June 30, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

GR (1)