Clomiphene Citrate Stair-Step Protocol

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03178500
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.9
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary	Drug: Clomiphene Citrate 50mg	N/A

Detailed Description

This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.

All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.

All patients will be devided according to computer based program into two groups First group:

Patients with traditional protocol

Traditional protocol:

Clomiphene citrate (clomid) (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 .

Second group: Patient with stair step protocol Follicular development will be monitored using transvaginal ultrasound at 11-14 day after (50mg) clomiphene for 5 days 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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial
• Actual Study Start Date: Feb 1, 2017
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Traditional 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 clomiphene adminstration
Experimental: Stair step protocol 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; stair-step clomiphene adminstration

Outcome Measures

Primary Outcome Measures

1. Occurrence of the ovulation by transvaginal ultrasound [20 days]

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

Secondary Outcome Measures

1. time to achieve ovulation [20 days]

   time for ovulation to occur

2. dose of clomiphene to achieve ovulation [20 days]

   the total dose of clomiphene used till ovulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age between 20-35 years.

• Body mass index (BMI/m2) 26-35 kg/m2

• Normal hystrosalpingogram (HSG).

• Normal Prolactin level.

• Normal semen analysis.

Exclusion Criteria:

• • They underwent ovarian drilling.

• Other factors infertility.

• AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

• Study Director: Adel S Salah El-Din, MD, Assistant Proffesor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ADEL SHAFIK SALAH EL-DIN, Assistant professor, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT03178500
• Other Study ID Numbers: STAIRSTEP TRIAL
• First Posted: Jun 7, 2017
• Last Update Posted: Jun 28, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by ADEL SHAFIK SALAH EL-DIN, Assistant professor, Ain Shams Maternity Hospital: clomiphene citrate; stair- step; poly cystic ovary
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Clomiphene; Enclomiphene; Zuclomiphene

Study Results

No Results Posted as of Jun 28, 2018