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…
ID
Bron
Verkorte titel
Aandoening
indomethacin; natural cycle IVF; modified natural cycle IVF; ovulation
Ondersteuning
Department of Obstetrics and Gynaecology
University Medical Center Groningen
University Medical Center Groningen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number/percentage of patients per study group that have one or more ovulations prior to follicle aspiration.
Achtergrond van het onderzoek
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 (Indocid®) 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).
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Use of indomethacin (Indocid®) 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).
Publiek
Department of Obstetrics and Gynaecology
M.L. Haadsma
Groningen
The Netherlands
+31 50-3616161
m.l.haadsma@og.umcg.nl
Wetenschappelijk
Department of Obstetrics and Gynaecology
M.L. Haadsma
Groningen
The Netherlands
+31 50-3616161
m.l.haadsma@og.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Indication for IVF or ICSI treatment;
2. Age 18 up to 37 years;
3. Ovulatory cycle of 26-35 days.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL656 |
NTR-old | NTR907 |
Ander register | : N/A |
ISRCTN | ISRCTN11805686 |