Clomiphene Citrate Stair-Step Protocol

NCT03178500 | Unknown

• 1 other identifier: STAIRSTEP TRIAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.

Conditions

Polycystic Ovary

Keywords

clomiphene citrate; stair- step; poly cystic ovary

Outcome Measures

Primary Outcomes (1)

• Occurrence of the ovulation by transvaginal ultrasound

  * Follicle suddenly disappears or regresses in size. * Irregular margins. * Intra follicular echos. Follicle suddenly becomes more echogenic. * Free fluid in pouch of douglas.

  20 days

Secondary Outcomes (2)

• time to achieve ovulation

  20 days

• dose of clomiphene to achieve ovulation

  20 days

Study Arms (2)

Traditional

EXPERIMENTAL

Clomiphene citrate (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded. If no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles.

Drug: Clomiphene Citrate 50mg

Stair step protocol

EXPERIMENTAL

If there is no response (no follicle \>10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US

Drug: Clomiphene Citrate 50mg

Interventions

Clomiphene Citrate 50mg DRUG

stair-step clomiphene adminstration

Stair step protocol; Traditional

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20-35 years.
• Body mass index (BMI/m2) 26-35 kg/m2
• Normal hystrosalpingogram (HSG).
• Normal Prolactin level.
• Normal semen analysis.

You may not qualify if:

• \- They underwent ovarian drilling.
• Other factors infertility.
• AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Adel S Salah El-Din, MD

  Assistant Proffesor

  STUDY DIRECTOR

Central Study Contacts

Adel S Salah El-Din, MD

CONTACT

01005223586; shafikadel@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: February 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

EG (1)