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Completed

NCT Number: NCT03755037

Clomiphene Citrate, Estradiol and Sildenafil for Induction of Ovulation in Unexplained Infertility

Diagnosis of unexplained infertility is made after the recommended testing fails to reveal any abnormality. The treatment for unexplained infertility is empiric because it does not address a specific defect or functional impairment. The principal treatments for unexplained infertility include expectant observation with timed intercourse and lifestyle changes, clomiphene citrate and intrauterine insemination (IUI), controlled ovarian hyperstimulation (COH) with IUI, and IVF).

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Key information

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Nesreen Abd El Fattah Abd Allah

Cairo, 11412, Egypt

About this study

Clomiphene citrate has been widely used alone, and in combination with intrauterine insemination (IUI), for treatment of unexplained subfertility, The mechanism of action is based on its mixed estrogenic and antiestrogenic properties. Clomiphene is frequently used to treat unexplained female infertility by inducing multifollicular response and correcting potential subtle ovulatory dysfunction .,)The American Society for Reproductive Medicine,2003).

The use of clomiphene citrate decreases the uterine blood flow during the early luteal phase, a periimplantation stage., )The American College of Obstetricians and Gynecologists,1995).

Although ovulation is found in 80% of women with a cumulative effect in 6-8 months, the pregnancy rate can still be very low in these women . The possible causes are the anti-estrogenic effects of CC at the endometrium and cervical mucus level . The endometrial effect is without doubt one of the most important handicaps in infertility treatment. The pregnancy rate can be very low, especially if the endometrial thickness (ET) is <6-8 mm ., )J Turk Ger Gynecol Assoc. ,2012).

Ethinyl E2 reverse the deleterious effect of CC on endometrial development during the follicular phase. Endometrial thickness was dependent on peak E2 concentrations in serum.,(Richard P. Dickey, et.al.,2003).

Sildenafil citrate could lead to an improvement in uterine blood flow and, in conjunction with estrogen, led to the estrogen-induced proliferation of the endometrial lining .

Sildenafil citrate enhances uterine blood flow and increases endometrial thickening . The achieved implantation depends on the blastocyst's ability to infiltrate the endometrium and develop a sustaining blood supply, which requires the following genes to produce the necessary proteins for digesting the endometrial cellular matrix, to regulate cell growth, and to induce angiogenesis (Razieh Dehghani Firouzabadi,et.al.,2013).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women whose infertility tests were normal then diagnosed as unexplained infertility.

Exclusion criteria

  • Any cause of infertility male factor, tubal or ovarian.
  • Chronic illness as cardiac or renal disease
  • Any contraindication for used drugs

Treatment and study plan

Clomid, Respatio and Ethinyl estradiol

Drug

Drugs were received during the menstrual cycle.

Primary outcomes

  1. Ultrasound parameters

    Time frame: at day 14 until day 17 of menstrual cycle

    Number of follicles in each ovary and endometrial thickness

Secondary outcomes

  1. Pregnancy

    Time frame: at day 21 and 24 of menstrual cycle

    A serum pregnancy test was done

Sponsors and collaborators

Lead sponsor

Nesreen Abdel Fattah Abdullah Shehata

Other

Collaborators

  • Beni-Suef University

Registry information

Official study title

Clomiphine Citrate and Estradiol Versus Clomiphine Citrate and Sildenafil in Comparison With Clomiphine Citrate Alone for Induction of Ovulation in Unexplained Infertility: Double Blind Randomised Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

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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