|- candidate number||5430|
|- NTR Number||NTR1702|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-mrt-2009|
|- Secondary IDs||P09-03 |
|- Public Title||Postcoital testing in anovulatory women.|
|- Scientific Title||THE POSTCOITAL TEST IN WHO CLASS II ANOVULATORY WOMEN;
USEFUL OR REDUNDANT? |
a prospective follow up study.
|- hypothesis||Pregnancy rates will not differ between patients with a positive and negative result of the PCT. |
|- Healt Condition(s) or Problem(s) studied||Anovulatory women|
|- 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||1. Women who remain anovulatory on CC 150 mg or who become anovulatory after initial ovulation;|
2. Known bilateral tubal obstruction.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-apr-2012|
|- Target number of participants||250|
|- 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 timing depends on the BBT and cycle length, the PCT is scheduled the day before the expected ovulation. In cases where the timing depends on ultrasound findings, the PCT is performed once the dominant follicle is ¡Ý 18 mm. The couple is asked to have intercourse before the appointment. The PCT is performed by cleaning the cervix, followed by suction of endocervical mucus using a 1 ml disposable syringe. Clarity and spinnbarkeit are assessed aiming for an optimal length of ¡Ý 7 cm. The PCT is judged to be normal if at least one progressive motile spermatozoon is seen in one of five high power fields at 400x magnification. All other PCT results are considered to be abnormal. If progressive motile spermatozoa are absent the test is scheduled again two days later or following the confirmation of a dominant follicle on ultrasound. |
|- Primary outcome||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 outcome||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.
|- Timepoints||At the pereformance of the postcoital test and after six months. |
|- Trial web site||www.studies-obsgyn.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marleen J Nahuis|
|- CONTACT for SCIENTIFIC QUERIES|| Marleen J Nahuis|
|- Sponsor/Initiator ||Medisch Spectrum Twente, Academic Medical Center (AMC), Amsterdam, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam, VU University Medical Center, Medisch Spectrum Twente|
|- Brief summary||Objective: |
To determine the value of a post coital test (PCT) in the basic fertility work up in WHO class II subfertile women ovulatory after clomiphene citrate (CC).
A prospective follow up study.
Patients with a history of subfertility and WHO class II anovulation, with normal prolactin (PRL) and thyroid stimulating hormone (TSH) levels, ovulatory after clomiphene citrate.
1. Age > 18 years;
2. Ovulation after incremental CC doses from 50 to 150 mg starting on day 3-5 for 5 days;
3. Partner with a total motile sperm count above 1 million.
1. Abnormal PRL or TSH value;
2. Known bilateral tubal pathology.
A basic fertility work up including a PCT.
Main outcome measure:
Pregnancy rates in women with a positive PCT compared to pregnancy rates in women with a negative PCT within a time horizon of six months.
|- Main changes (audit trail)|
|- RECORD||9-mrt-2009 - 14-sep-2009|