Prevention of multiple pregnancies in couples with unexplained or mild male subfertility

Completed

Conditions: Multiple pregnancies
Pregnancy and Childbirth

Registration Number: ISRCTN52843371

Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 600

Inclusion Criteria

Couples are eligible if the following apply:
1. Females aged between 18 and 38 years
2. Failure to conceive within at least 12 months of unprotected intercourse
3. The couple has poor fertility prospects as calculated by the validated model of Hunault. A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months

Exclusion Criteria

Couples must not be entered if any of the following apply:
1. Polycystic ovary syndrome or any other anovulation
2. Post-wash total motile sperm count below 3 million
3. Double-sided tubal pathology
4. Endocrinopathological disease like:
a. Cushing syndrome
b. adrenal hyperplasia
c. hyperprolactinaemia
d. acromegaly
e. imminent ovarian failure
f. premature ovarian failure
g. hypothalamic amenorrhoea
h. hypothyroidy
i. diabetes mellitus type one
5. Negative post-coitus test
6. If not willing or able to sign the consent form

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth of a healthy child.

Secondary Outcome Measures

Name	Time	Method
1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation<br>2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography<br>3. Neonatal mortality<br>4. Pregnancy complications:<br>a. preterm birth less than 37 weeks<br>b. birth weight less than 2.500 grams<br>c. Pregnancy Induced Hypertension (PIH)<br>d. (pre)-eclampsia, HELLP (Haemolysis, Elevated Liver enzymes, Low blood levels of Platelets)<br>5. Costs