Condition category
Pregnancy and Childbirth
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
12/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M L Haadsma

ORCID ID

Contact details

University Medical Centre Groningen
Department of Obstetrics and Gynaecology
Groningen
9700 RB
Netherlands
+31 (0)50 361 6161
m.l.haadsma@og.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study 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 In-Vitro Fertilisation-treatment in the Modified Natural Cycle (IVF-MNC) significantly decreases the number of patients with one or more premature ovulations compared to placebo.

Ethics approval

Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie UMC Groningen) on the 24th June 2005 (ref: 2005/074).

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

In-vitro fertilisation-treatment in the modified natural cycle, IVF in the natural cycle

Intervention

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 seven capsules per cycle).

Intervention type

Drug

Phase

Not Specified

Drug names

Indomethacin (Indocid®)

Primary outcome measures

Number/percentage of patients per study group that have one or more ovulations prior to follicle aspiration.

Secondary outcome measures

Number/percentage of patients per study group that achieve an on-going pregnancy (defined as an intact intra-uterine pregnancy at 12 weeks gestation)

Overall trial start date

05/12/2005

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Indication for IVF or Intracytoplasmic Sperm Injection (ICSI) treatment
2. Age 18 up to 37 years
3. Ovulatory cycle of 26 to 35 days

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

1. Prior IVF or ICSI treatment unless the last treatment was successful
2. Ovarian cysts disabling adequate sonographic assessment of the ovaries
3. Contraindications for indomethacin, such as asthma or prior gastro-intestinal ulcer

Recruitment start date

05/12/2005

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen (UMCG) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes