hCG Priming in Women With Diminished Ovarian Reserve

NCT07108621 | Recruiting Phase 3 DMC

• 2 other identifiers: 2025-521234-282025-521234-28-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial is to further examine the possible effects of low dose human chorionic gonadotropin (hCG) priming for eight weeks in women with diminished ovarian reserve (DOR) undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). The investigators want to retest the findings of our first study in an identical paired design (NCT04643925), as an increase of 1.5 in mean number of oocytes retrieved is clinically relevant. To incorporate the strengths of a randomized controlled trial design, women will be randomized after their first ICSI treatment to receive either hCG or placebo in a double-blinded design during an eight-week priming period preceding their second ICSI treatment. The primary outcome is the number of oocytes retrieved in the second ICSI treatment.

Conditions

Infertility, Female; Ovarian Reserve; In Vitro Fertilization (IVF)

Keywords

hCG priming; Androgen priming; Diminished ovarian reserve; In vitro fertilization (IVF); Controlled ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  The number of oocytes retrieved in the ICSI II treatment performed after hCG priming/placebo

  Through study completion, an average of 4 months

Secondary Outcomes (1)

• Number of mature oocytes

  Through study completion, an average of 4 months

Other Outcomes (17)

• Antral follicle count

  Through study completion, an average of 4 months

• AMH

  Through study completion, an average of 4 months

• Number of pre-ovulatory follicles >16 mm

  Through study completion, an average of 4 months

Study Arms (2)

hCG Priming

EXPERIMENTAL

Women in the experimental group will undergo the following treatment in order: A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. Priming period: hCG priming 260 IU once daily for two menstrual cycles (approximately 8 weeks). A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.

Drug: Choriongonadotropin alfa (hCG)

Placebo

PLACEBO COMPARATOR

Women in the placebo group will undergo the following treatment in order: A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. Priming period: Placebo (isotone NaCl) injections once daily for two menstrual cycles (approximately 8 weeks). A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.

Drug: Isotonic NaCl (Placebo)

Interventions

Choriongonadotropin alfa (hCG) DRUG

hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF/ICSI.

hCG Priming

Isotonic NaCl (Placebo) DRUG

Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF/ICSI.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 (both inclusive)
• Regular menstrual cycle (23-35 days)
• AMH \< 6.29 pmol/L (Elecsys® AMH assay)

You may not qualify if:

• Uterine malformations or hydrosalpinx
• Submucosal uterine myomas
• Uterine polyps
• Allergy to standard IVF/ICSI medication
• Endometriosis stage III-IV
• Preimplantation genetic testing
• Testicular sperm aspiration/extraction
• Ovarian enlargement or cysts (other than normally occurring corpora luteae)
• Gynaecological haemorrhages of unknown aetiology
• Known severe comorbidity\*
• i.e., Insulin dependent diabetes mellitus, non-insulin dependent diabetes mellitus, gastrointestinal, cardiovascular, thromboembolic (including active thromboembolic disorders), pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulated thyroid disease, tumors of the hypothalamus or pituitary gland or ovarian, uterine, or mammary carcinoma.

Sponsors & Collaborators

• Kristine Loessl: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• Friis Wang N, Bogstad JW, Pors SE, Petersen MR, Pinborg A, Yding Andersen C, Lossl K. Eight weeks of androgen priming by daily low-dose hCG injections before ICSI treatment in women with low ovarian reserve. Hum Reprod. 2023 Apr 3;38(4):716-725. doi: 10.1093/humrep/dead012.

  PMID: 36721920 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Kristine Løssl, Associate Professor, PhD, MD

CONTACT

+4535451077; kristine.loessl@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor, Ph.D., MD

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2031
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available starting 3 months after trial completion. Data will remain available for up to 25 years after study completion, in accordance with EU and Danish regulatory requirements for clinical trials involving medicinal products.
• Access Criteria: Approvals by necessary ethic committees and the Danish Data Protection Agency will be needed before sharing of data. All costs for data sharing will be covered by the party requesting the data. Data cannot be shared with research groups working on overlapping primary and secondary outcomes without prior discussion and agreement to avoid duplication of work. Requests for such use will be considered on a case-by-case basis. To gain access, data requestors will need to sign a data sharing agreement. Proposals of data sharing should be directed to kristine.loessl@regionh.dk.

Locations

DK (1)