Overview

Predicting Ovarian Response in Artificial Insemination With Low Stimulation

Status:
Unknown status
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Isala
Collaborator:
Merck Serono International SA
Treatments:
Follicle Stimulating Hormone
Hormones
Criteria
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