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OpenTrials
Completed

NCT Number: NCT01046708

Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≤ 36 years
  • Body mass index between 18 and 29
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
  • Patients can enter the study only once.
  • Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
  • Normal HSG (maximum 3 months prior starting the stimulation).
  • Donor sperm can be included

Exclusion criteria

  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Endometriosis(≥AFS III)

Treatment and study plan

Micronized progesterone

Drug

600mg in 3 separate doses per day

Other names: utrogestan

Primary outcomes

  1. ongoing pregnancy rate

    Time frame: 1 year

Secondary outcomes

  1. implantation rate,clinical pregnancy rate

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Jan 12, 2010
Registry last updated
Jul 3, 2013

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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