hCG Priming in Women With Low Ovarian Reserve

NCT ID: NCT04643925

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-27
• Study Completion Date: 2021-08-31

Brief Summary

The aim of this trial is to examine the possible effects of hCG administration for eight weeks prior to IVF/ICSI in women with low ovarian reserve. Primary outcome is the proportion of the antral follicle count that reach the pre-ovulatory stage.

Detailed Description

One of the fundamental goals in In Vitro Fertilisation (IVF) is obtaining a high number of good quality oocytes, in order to select and transfer embryos with the highest possible implantation potential thereby optimizing the chance of a pregnancy and ultimately a live birth. This is done by applying an individualized controlled ovarian stimulation (iCOS) protocol, primarily based on ovarian reserve markers like antral follicle count (AFC) and Anti-Müllerian hormone (AMH), when deciding the follicle stimulating hormone (FSH) stimulation dose. Certain patients, the so called "poor ovarian responders' (PORs), pose a clinical challenge because they have a poor ovarian reserve and develop a limited number of pre-ovulatory follicles in respond to ovarian stimulation despite high FSH stimulation doses, thus experiencing reduced live birth rates.

The aim of the present study is to examine the possible effects of long-term LH activity by the administration of hCG for eight weeks in between two identical IVF/ICSI cycles and compare cycle characteristics and outcome. The primary outcome is the follicular output rate (FORT) which reflects the proportion of antral follicles at the start of controlled ovarian stimulation that reaches the pre-ovulatory state. Secondary outcomes include amongst others AMH and antral follicle count at baseline (cd 2-3), number of pre-ovulatory follicles, oocytes retrieved, and embryos developed.

We hypothesize that eight weeks of androgen priming by hCG increases the proportion of antral follicles that reaches the pre-ovulatory state during controlled ovarian stimulation for IVF/ICSI in women with poor ovarian reserve.

Conditions

Infertility, Female; Ovarian Reserve; In Vitro Fertilization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hCG priming

Control cycle: 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 the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy.

Study cycle: hCG priming by Ovitrelle 260 IE once daily for 8 weeks followed by 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 the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by a single blastocyst transfer at day 5.

Group Type: EXPERIMENTAL

Ovitrelle

Intervention Type: DRUG

Ovitrelle 260 IE once daily for 8 weeks prior to IVF/ICSI

Interventions

Ovitrelle

Ovitrelle 260 IE once daily for 8 weeks prior to IVF/ICSI

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Regular menstrual cycle (23-35 days)
• 1.-5. IVF/ICSI cycle at inclusion
• AMH < 6.29 pmol/L (Elecsys® AMH assay)

Exclusion Criteria

• Uterine malformations or hydrosalpinx
• Submucosal uterine myomas
• Uterine polyps
• Allergy to standard IVF/ICSI medication
• Endometriosis stage III-IV
• Severe comorbidity
• Preimplantation genetic testing
• Testicular sperm aspiration/extraction
• Tumors in the hypothalamus or pituitary gland
• Active thromboembolic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Kristine Loessl

Consultant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anja B Pinborg, MD

Role: STUDY_DIRECTOR

The Fertility Department, Rigshospitalet

Locations

Rigshospitalet

København Ø, , Denmark

Countries

Denmark

References

Friis Wang N, Bogstad JW, Petersen MR, Pinborg A, Yding Andersen C, Lossl K. Androgen and inhibin B levels during ovarian stimulation before and after 8 weeks of low-dose hCG priming in women with low ovarian reserve. Hum Reprod. 2023 Sep 5;38(9):1807-1815. doi: 10.1093/humrep/dead134.

Reference Type: DERIVED

PMID: 37354554 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36721920 (View on PubMed)

Other Identifiers

73908

Identifier Type: -

Identifier Source: org_study_id