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

ISRCTN	ISRCTN11805686
DOI	https://doi.org/10.1186/ISRCTN11805686
Secondary identifying numbers	NL656 (NTR907)

Submission date: 07/03/2007
Registration date: 07/03/2007
Last edited: 26/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M L Haadsma
Scientific

University Medical Centre Groningen
Department of Obstetrics and Gynaecology
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 6161
Email	m.l.haadsma@og.umcg.nl

Study information

Study design	Randomised, placebo controlled, parallel group, double blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Efficacy of indomethacin in in-vitro fertilisation treatment in the modified natural cycle
Study objectives	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(s)	Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie UMC Groningen) on the 24th June 2005 (ref: 2005/074).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Indomethacin (Indocid®)
Primary outcome measure	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 study start date	05/12/2005
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	120
Key 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
Key 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
Date of first enrolment	05/12/2005
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Groningen

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Groningen
9700 RB
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Hospital/treatment centre

University Medical Centre Groningen (UMCG) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan