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Efficacy of indomethacin in in vitro fertilisation treatment in the modified natural cycle.


- candidate number2463
- NTR NumberNTR907
- ISRCTNISRCTN11805686
- Date ISRCTN created7-mrt-2007
- date ISRCTN requested6-mrt-2007
- Date Registered NTR13-feb-2007
- Secondary IDsN/A 
- Public TitleEfficacy of indomethacin in in vitro fertilisation treatment in the modified natural cycle.
- Scientific TitleEfficacy of indomethacin in in the prevention of premature ovulation in in vitro fertilisation treatment in a with a GnRH-antagonist modified natural cycle.
- ACRONYMN/A
- hypothesisIndomethacin is known to be a strong inhibitor of ovulation in the spontaneous menstrual cycle. Therefore we assume that the use of indomethacin prior to follicle aspiration in IVF-treatment in the modified natural cycle (IVF-MNC) significantly decreases the number of patients with one or more premature ovulations compared to placebo.
- Healt Condition(s) or Problem(s) studiedIn vitro fertilization (IVF), Indomethacin, Natural cycle, Modified natural cycle IVF, Ovulation
- Inclusion criteria1. Indication for IVF or ICSI treatment;
2. Age 18 up to 37 years;
3. Ovulatory cycle of 26-35 days.
- Exclusion criteria1. Prior IVF or ICSI treatment unless the last treatment was succesfull;
2. Ovarian cysts disabling adequate sonographic assessment of the ovaries;
3. Contra-indications for indomethacin, such as asthma or prior gastro-intestinal ulcer.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-dec-2005
- planned closingdate1-nov-2007
- Target number of participants120
- InterventionsUse of indomethacin (IndocidŽ) 50 mg versus placebo during IVF-treatment in the modified natural cycle.
Dosage scheme: three times a day, starting on the day of ovulation triggering and ending on the morning of the follicle aspiration (total of 7 capsules per cycle).
- Primary outcomeNumber/percentage of patients per study group that have one or more ovulations prior to follicle aspiration.
- Secondary outcomeNumber/percentage of patients per study group that achieve an ongoing pregnancy (defined as an intact intra-uterine pregnancy at 12 weeks gestation).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. M.L. Haadsma
- CONTACT for SCIENTIFIC QUERIESDrs. M.L. Haadsma
- Sponsor/Initiator University Medical Center Groningen, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen, Department of Obstetrics and Gynaecology
- PublicationsN/A
- Brief summaryIndomethacin is known to be a strong inhibitor of ovulation in the spontaneous menstrual cycle. Therefore we assume that the use of indomethacin prior to follicle aspiration in IVF-treatment in the modified natural cycle (IVF-MNC) significantly decreases the number of patients with one or more premature ovulations compared to placebo. To test this hypothesis we designed a double-blinded placebo-controlled randomised trial with two groups of 60 participants undergoing IVF or ICSI treatment in the modified natural cycle. The study medication, indomethacin (IndocidŽ) 50 mg or placebo, was taken three times a day, starting on the day of ovulation triggering and ending on the morning of the follicle aspiration (total of 7 capsules per cycle) up to a maximum of six cycles.
Primary outcome is the number/percentage of patients per study group that have one or more ovulations prior to follicle aspiration. Secondary outcome is the number/percentage of patients per study group that achieve an ongoing pregnancy (defined as an intact intra-uterine pregnancy at 12 weeks gestation).
- Main changes (audit trail)
- RECORD13-feb-2007 - 13-jan-2010


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