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Completed

NCT Number: NCT04643925

hCG Priming in Women With Low Ovarian Reserve

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female In Vitro Fertilization Infertility Ovarian Reserve Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet

København Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ovitrelle

Drug

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

Primary outcomes

  1. Follicular output rate

    Time frame: Through study completion, an average of 5 months

    Follicular Output Rate (FORT: pre-ovulatory follicle count (>16 mm) at hCG trigger day/antral follicle count at baseline (2-10 mm).

Secondary outcomes

  1. Antral follicle count (≤10 mm) at baseline (cd 2-3)

    Time frame: Through study completion, an average of 5 months

  2. AMH at baseline (CD 2-3)

    Time frame: Through study completion, an average of 5 months

  3. Number of pre-ovulatory follicles >16 mm on trigger day

    Time frame: Through study completion, an average of 5 months

  4. Number of follicles >14 mm and >12 mm, >10 mm and ≤10 mm on hCG trigger day

    Time frame: Through study completion, an average of 5 months

  5. Number of oocytes retrieved

    Time frame: Through study completion, an average of 5 months

  6. Number of mature (MII) oocytes

    Time frame: Through study completion, an average of 5 months

  7. Number of fertilized eggs (2pn)

    Time frame: Through study completion, an average of 5 months

  8. Number of cleaved day 2 embryos

    Time frame: Through study completion, an average of 5 months

  9. Number of good quality day 2 embryos

    Time frame: Through study completion, an average of 5 months

  10. Number of top quality day 2 embryos

    Time frame: Through study completion, an average of 5 months

  11. Number of blastocysts (Gardner score 1-6)

    Time frame: Through study completion, an average of 5 months

  12. Number of good quality blastocysts day 5/6

    Time frame: Through study completion, an average of 5 months

  13. Number of vitrified embryos/blastocysts

    Time frame: Through study completion, an average of 5 months

  14. Total number of transferred or vitrified blastocysts

    Time frame: Through study completion, an average of 5 months

  15. The number of cancelled cycles and the reasons for cancellation in the two groups

    Time frame: Through study completion, an average of 5 months

  16. Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione and Inhibin B

    Time frame: Through study completion, an average of 5 months

  17. Granulosa/cumulus cell FSH and LH receptor expression

    Time frame: 1 year

  18. Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D).

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Eight Weeks of Androgen Priming by hCG Before IVF/ICSI in Women With Low Ovarian Reserve

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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