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

NCT03755037 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Beni-Suef 16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• Ultrasound parameters

  Number of follicles in each ovary and endometrial thickness

  at day 14 until day 17 of menstrual cycle

Secondary Outcomes (1)

• Pregnancy

  at day 21 and 24 of menstrual cycle

Study Arms (3)

Estradiol and cc

ACTIVE COMPARATOR

Group 1 received estradiol, cc and placebo simillar to sildenafil for induction of ovulation. CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient then ethinyl estradiol 0.05mg orally twice daily on the 8th day of same cycle till 11th day.

Drug: Clomid, Respatio and Ethinyl estradiol

Sildenafil and cc

ACTIVE COMPARATOR

Group 2 received CC 50 mg (clomid) orally twice daily from 3rd day to 7th day of menstrual cycle of the patient, sildenafil citrate (Respatio) 20 mg tab orally 3 times daily from8th day of same cycle till 11th day and placebo simillar to estradiol.

Drug: Clomid, Respatio and Ethinyl estradiol

Placebo and cc

PLACEBO COMPARATOR

Group 3 received cc and placebo similar to sildenafil and placebo similar to estradiol with the same doses.

Drug: Clomid, Respatio and Ethinyl estradiol

Interventions

Clomid, Respatio and Ethinyl estradiol DRUG

Drugs were received during the menstrual cycle.

Estradiol and cc; Placebo and cc; Sildenafil and cc

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: female unexplained infertility patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nesreen Abdel Fattah Abdullah Shehata: lead
• Beni-Suef University: collaborator

Study Sites (1)

Nesreen Abd El Fattah Abd Allah

Cairo, 11412, Egypt

Location

Related Publications (1)

• 1. Alexander Quaas, MD, Ph .D .,and Anuja Dokras, MD . diagnosis and treatment of unexplainrd infertilityRev Obstet Gynecol. 2008 Spring; 1(2): 69-76 2. J Turk Ger Gynecol Assoc.: The effect of administering estrogen to clomiphene citrate stimulated cycles on endometrial thickness and pregnancy rates in unexplained infertility. (2012) . Sep 1;13(3):157-61. 3. Paulus WE, Strehler E, Zhang M, Jelinkova L,El-Danasouri I and Sterzik K. : Benefit of sildenafil citrate in assisted reproductivetherapy. Fertil Steri 2002 Apr;77(4):846-7. 4. Razieh Dehghani Firouzabadi, M.D., Robab Davar, M.D., Farzaneh Hojjat, M.D., and Mohamad Mahdavi, M.D. :effect of sildenafil on endomeerial preparation and outcome of frozen_thawed embryo transfer cycles(. Iran J Reprod Med. 2013 Feb; 11(2): 151-158. 5. Richard P. Dickey, M.D., Ph.D.,):clomiphene citrate for woman with unexplained infertility . pp 261-271 13 May 2015 6. The American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women:. Fertil Steril . Fertil Steril. 2013 Aug;100(2):341-8. doi: 10.1016/j.fertnstert.2013.05.033. Epub 2013 Jun 27.

  BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Clomiphene; Ethinyl Estradiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind randomisation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: Women with unexplained infertility (n=150) were divided into 3 equal groups. Group 1 received estradiol and clomiphine citrate (cc), group 2 received sildenafil and cc and group 3 cc and placebo.

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 27, 2018
• Study Start: January 31, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)