Eight weeks of pre-treatment with hCG before in vitro fertilization in women with low ovarian reserve.

Eight weeks of androgen priming by hCG before IVF/ICSI in women with low ovarian reserve. - hCG priming in women with low ovarian reserve

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002453-26-DK

Enrollment

Registered

2020-06-09

Start date

2020-11-18

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility MedDRA version: 20.1 Level: LLT Classification code 10016399 Term: Female infertility (primary) System Organ Class: 100000004872

Interventions

Trade Name: Ovitrelle Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Choriongonadotropin-alfa (hCG) Other descriptive name: HUMAN CHORIONIC GONADOTROPIN Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-40 (both inclusive); regular menstrual cycle between 23 and 35 days; AMH =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria are uterine malformations, submucosal myomas, intrauterine polyps, hydrosalpinx, endometriosis stage III-IV, severe comorbidity (i.e. IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulation of thyroid disease), need for testicular sperm aspiration, preimplantation genetic testing, not Danish or English speaking, previous inclusion, or allergy to Ovitrelle or other standard IVF medication.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Follicular output rate (FORT) = the proportion of the antral follicle count that reach the pre-ovulatory stage.;Timepoint(s) of evaluation of this end point: At the end of the IVF study cycle.;Secondary Objective: Not applicable;Main Objective: The primary objective of this study is to investigate in a paired design if eight weeks of hCG pre-treatment improves responsiveness to ovarian stimulation during IVF/ICSI in women with low ovarian reserve.	—

Measure

Time frame

Primary end point(s): Follicular output rate (FORT) = the proportion of the antral follicle count that reach the pre-ovulatory stage.;Timepoint(s) of evaluation of this end point: At the end of the IVF study cycle.;Secondary Objective: Not applicable;Main Objective: The primary objective of this study is to investigate in a paired design if eight weeks of hCG pre-treatment improves responsiveness to ovarian stimulation during IVF/ICSI in women with low ovarian reserve.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: During the control and study cycle and regarding cumulus and granulosa cell investigations no later than one year after inclusion of the last patient. ;Secondary end point(s): •Antral follicle count (2-10 mm) at baseline (cd 2-3) •AMH at baseline (cd 2-3) •Number of pre-ovulatory follicles >16 mm on trigger day •Number of follicles >14 mm and >12 mm >10 mm and =10 mm on hCG trigger day •Number of oocytes retrieved •Number of mature (MII) oocytes •Number of fertilized eggs (2pn) •Number of cleaved day 2 embryos •Number of good quality day 2 embryos •Number of top quality day 2 embryos •Number of blastocysts (Gardner score 1-6) •Number of good quality blastocysts day 5/6 •Number of vitrified embryos/blastocysts •Total number of transferred or vitrified blastocysts •The number of cancelled cycles and the reasons for cancellation in the two groups •Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione) •Granulosa/cumulus cell FSH and LH receptor expression •Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: During the control and study cycle and regarding cumulus and granulosa cell investigations no later than one year after inclusion of the last patient. ;Secondary end point(s): •Antral follicle count (2-10 mm) at baseline (cd 2-3) •AMH at baseline (cd 2-3) •Number of pre-ovulatory follicles >16 mm on trigger day •Number of follicles >14 mm and >12 mm >10 mm and =10 mm on hCG trigger day •Number of oocytes retrieved •Number of mature (MII) oocytes •Number of fertilized eggs (2pn) •Number of cleaved day 2 embryos •Number of good quality day 2 embryos •Number of top quality day 2 embryos •Number of blastocysts (Gardner score 1-6) •Number of good quality blastocysts day 5/6 •Number of vitrified embryos/blastocysts •Total number of transferred or vitrified blastocysts •The number of cancelled cycles and the reasons for cancellation in the two groups •Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione) •Granulosa/cumulus cell FSH and LH receptor expression •Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D)

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Countries

Denmark

Contacts

Public ContactFertility Research

Rigshospitalet

fertilitet.rigshospitalet@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026