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Postcoital testing in anovulatory women.

THE POSTCOITAL TEST IN WHO CLASS II ANOVULATORY WOMEN; USEFUL OR REDUNDANT? a prospective follow up study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24105
Enrollment
250
Registered
2009-03-09
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

anovulatory WHO class II women, ovulatory with clomiphene citrate.

Interventions

At least one PCT is performed during the basic fertility work-up. The test should be planned based on the basal body temperature (BBT) curve, ultrasound findings or cycle history. In couples where the

Sponsors

Medisch Spectrum Twente Enschede Academisch Medisch Centrum Amsterdam Vrije Universiteit Medisch Centrum Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. WHO class II anovulatory women who ovulate following use of incremental CC doses from 50 to 150 mg starting on dag 3-5 following 5 days of the cycle; 2. All patients have normal serum prolactin (0,05 ¨C 0,80 IU/l) and thyroid-stimulating hormone (0,4 - 4,0 mU/l); 3. Age > 18 years; 4. A partner with total motile sperm count above 1 million, according to the modified criteria of the World Health Organization (1999).

Exclusion criteria

Exclusion criteria: 1. Women who remain anovulatory on CC 150 mg or who become anovulatory after initial ovulation; 2. Known bilateral tubal obstruction.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the occurrence of an ongoing, vital intra-uterine singleton pregnancy. An ongoing, vital pregnancy is defined as fetal heart beat seen by transvaginal ultrasonography at 12 weeks gestation. If no pregnancy occurs, follow-up ends after the sixth cycle.

Secondary

MeasureTime frame
1. Positive pregnancy test; 2. Occurrence of ovulation; 3. Total number of postcoital tests performed; 4. Median time to pregnancy; 5. Clinical pregnancy, defined as any registered heart beat at sonography; 6. Miscarriage, defined as loss of an intra uterine pregnancy (confirmed by ultrasound or histologic examination) before the 20th week of pregnancy; 7. Multiple pregnancy, defined as a registered heart beat of at least two fetuses at 12 weeks of gestation.

Contacts

Public ContactMarleen J Nahuis

Medisch Spectrum Twente Locatie Enschede Ariënsplein

marleennahuis@hotmail.com+31 (0)53 4872330

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)