Study on the fertility of women treated with triptorelin for precocious puberty in their childhood (PREFER)

Study identification

• EU PAS number:
  EUPAS7895
• Study ID:
  30165
• Official title and acronym:
  Study on the fertility of women treated with triptorelin for precocious puberty in their childhood (PREFER)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  PREFER is a longitudinal, prospective, descriptive, non-comparative epidemiological study of women treated during childhood for precocious puberty with the Gonadotrophin Releasing Hormone (GnRH) analogue, triptorelin. The study examined the fertility of these women during the 2 years prior to inclusion and during the follow-up period (1 year). The women were sent questionnaires by post once their informed consent forms had been returned to the paediatric service that treated them for precocious puberty during their childhood. Only clinical pregnancies should be considered, i.e. confirmed by a menstrual delay greater than 15 days and ultrasound evidence (at least a gestational sac). The fertility of these women should be compared to data in the literature for women of comparable age. The study objective was to determine whether women treated during childhood for precocious puberty with triptorelin have the same one-year pregnancy rates than couples trying to conceive, i.e. approximately 85% according to numerous publications 12-15. It was planned to also compare the results of the PREFER study to the fertility of French couples and their Waiting Time to Pregnancy (WTP), based on various socio-economic and demographic data generated by a survey on the fertility in France (Génération et Genre), conducted at the end of 2005 jointly by INED (Institut National d’Etudes Démographiques) and INSEE (Institut National de la Statistique et des Etudes Economiques) on a sample of 10,000 people representative of the French population.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 23 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/01/2007

Actual: 01/01/2007

Study start date

Planned: 01/02/2007

Actual: 01/02/2007

Date of final study report

Planned: 31/12/2010

Actual: 05/09/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

IPSEN Pharma

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable