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Completed

NCT Number: NCT01604044

Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.

This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

35 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Policlinico Agostino Gemelli

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women with story of infertility sine causa and mild-moderate male factor
  • regular ovulatory menstrual cycles
  • BMI ≤27 kg/m2
  • normal day 3 hormonal pattern
  • bilateral tubal patency

Exclusion criteria

  • mono/bilateral tubal occlusion,
  • severe male factor
  • polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities
  • pelvic inflammatory disease
  • endometriosis
  • sexual organ malformations
  • neoplasms or breast pathology incompatible with gonadotropin stimulation.

Treatment and study plan

Meropur 150 a day

Drug

one subcutaneous injection a day

Gonal-f 150 plus Luveris 150

Drug

one subcutaneous injection a day

Primary outcomes

  1. ongoing pregnancy rate

    Time frame: 12 weeks

Secondary outcomes

  1. number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies

    Time frame: 30 days

Other outcomes

  1. duration of stimulation, total gonadotropin dose, number of midsize follicles, dominant follicles, E2 levels, endometrial thickness on hCG day, Progesterone levels, endometrial thickness on the midluteal phase.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 23, 2012
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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