To determine the value of a post coital test in the basic fertility work up in WHO class II subfertile women ovulatory after clomiphene citrate (CC).
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pregnancy rates in women with a positive compared to pregnancy rates in women
with a negative postcoital test within a time horizon of six months
Secondary outcome
• Positive pregnancy test
• occurrence of ovulation
• total number of postcoital tests performed
• median time to pregnancy in the two groups.
• clinical pregnancy, defined as any registerd heart beath at sonography
• miscarriage, defined as loss of an intra uterine pregnancy (confirmed by
ultrasound or histologic examination) before the 20th week of pregnancy.
• multiple pregnancy, defined as a registered heart beath of at least two
fetuses at 12 weeks of gestation
• costs
Background summary
High quality studies randomized or non randomized, in which the predictive
value or the additional benefit of treatment with a negative PCT in WHO class
II patients ovulatory on CC are lacking. In the guidelines from the Dutch
society for Obstetrics and Gynecology, the PCT is mentioned among the care for
couple with subfertility. However the guideline is unspecific about the
interpretation of the PCT in relation to subsequent management.
In view of this lack of knowledge, we decided to evaluate whether a post coital
test should be performed among WHO class II anovulatory patients who became
ovulatory after treatment with CC.
Study objective
To determine the value of a post coital test in the basic fertility work up in
WHO class II subfertile women ovulatory after clomiphene citrate (CC).
Study design
A prospective follow up study.
Study burden and risks
no additional risk.
areinsplein 1
7511 JX Enschede
NL
areinsplein 1
7511 JX Enschede
NL
Listed location countries
Age
Inclusion criteria
- WHO class II anovulatory women who ovulate following use of incremental CC doses from 50-150 mg starting on day 3-5 during 5 days of the cycle.
- normal serum prolactin (0,05 - 0,80 IU/l, and TSH (0,4-4,0 mU/l
- age 18 years or older
- total motial sperm count above 1 million, according the modified criteria of the WHO
Exclusion criteria
- anovulatory on CC 150 mg / day
- known bilateral tubel pathology
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27135.044.09 |
| Other | NTR |