Predicting Ovarian Response in Artificial Insemination With Low Stimulation

Isala

Status: Unknown

Conditions: Subfertility

Treatments: Drug: Follicle Stimulating Hormone

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01662180

PRORAILS trial

Details and patient eligibility

About

This large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH.

Full description

A multi-center, open-label, prospective cohorts study. Patients with a regular indication for COH/IUI (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. Patient's characteristics will be documented including age, weight, BMI, smoking status, cycle day 2 3 or 4 FSH /Estradiol levels, antral follicle count, and AMH. AMH and FSH/Estradiol will be determined centrally after completion of inclusion of all patients in the study. All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. Ovarian response will be documented by ultrasound only. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Cancellation criteria will be defined according to the national guidelines provided by the NVOG (7).

Enrollment: 510 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• couples with unexplained or mild male subfertility (1-3) and a spontaneous chance of conception below 40% (Hunault score).
• Unexplained subfertility including minimal to mild endometriosis (AFS grade 1 or 2) is defined as the failure to conceive after at least one year of unprotected intercourse whereas the standard fertility work-up was unable to detect any factors that might influence fertility negatively.
• semen analysis should be normal according to the WHO guidelines (8),
• ovulation should be documented (by BBT charts, ovulation detection by ultrasound or normal luteal progesterone values),
• tubal patency should be confirmed (HSG, laparoscopy or fertiloscopy) and when a postcoital test was performed a cervical factor should have been excluded.
• Mild male subfertility is defined as abnormal semen parameters according to the WHO (8) but an average total motile sperm account before processing of at least 10 million.

Exclusion criteria

• Hunault score ≥ 40%
• Endometriosis AFS grade 3 or 4
• Contra-indications for the use of gonadotrophins (cysts larger than 2 cm, allergy for gonadotrophins)
• Total motile sperm count after sperm processing below 1 million
• Women aged younger than eighteen years or older than 45 years.
• Previous treatment with COH/IUI for treating current subfertility
• Unable to speak or read the Dutch language

Trial design

510 participants in 1 patient group

Subfertile couples

Description:

Subfertile couples presenting at fertility clinics with an indication for IUI in stimulated cycles All patients will receive a fixed 75 IU recombinant follicle stimulating hormone per day conform normal stimulation protocol starting from cycle day 3, 4 or 5. Once the dominant follicle(s) reach a mean diameter of 16-18 mm, hCG (5000IU or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. Patients will be followed for the time of one menstrual cycle.

Treatment:

Drug: Follicle Stimulating Hormone