| - candidate number | 2463 |
| - NTR Number | NTR907 |
| - ISRCTN | ISRCTN11805686 |
| - Date ISRCTN created | 7-mrt-2007 |
| - date ISRCTN requested | 6-mrt-2007 |
| - Date Registered NTR | 13-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Efficacy of indomethacin in in vitro fertilisation treatment in the modified natural cycle. |
| - Scientific Title | Efficacy of indomethacin in in the prevention of premature ovulation in in vitro fertilisation treatment in a with a GnRH-antagonist modified natural cycle. |
| - ACRONYM | N/A |
| - hypothesis | Indomethacin 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) studied | In vitro fertilization (IVF), Indomethacin, Natural cycle, Modified natural cycle IVF, Ovulation |
| - Inclusion criteria | 1. Indication for IVF or ICSI treatment; 2. Age 18 up to 37 years; 3. Ovulatory cycle of 26-35 days. |
| - Exclusion criteria | 1. 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 received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 5-dec-2005 |
| - planned closingdate | 1-nov-2007 |
| - Target number of participants | 120 |
| - Interventions | Use 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 outcome | Number/percentage of patients per study group that have one or more ovulations prior to follicle aspiration. |
| - Secondary outcome | Number/percentage of patients per study group that achieve an ongoing pregnancy (defined as an intact intra-uterine pregnancy at 12 weeks gestation). |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. M.L. Haadsma |
| - CONTACT for SCIENTIFIC QUERIES | Drs. 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 |
| - Publications | N/A |
| - Brief summary | Indomethacin 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) | |
| - RECORD | 13-feb-2007 - 13-jan-2010 |
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