Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 2 With and Without Suppression by Dienogest

June 20, 2017 updated by: Alhassan Mohammad Khedr, Ain Shams University

Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 11 With and Without Suppression by Dienogest

This study aims at investigating the fertility outcome of endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month in endometriosis patients stage I and II.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study population: Sample size:

Group sample sizes of this study is 155 in group one and 155 in group two achieve 80% power to detect a difference between the group proportions of 0.10. The proportion in group one (the treatment group) is assumed to be 0.1000 under the null hypothesis and 0.2000 under the alternative hypothesis. The proportion in group two (the control group) is 0.1000. The test statistic used is .the one-sided Z test with un pooled variance. The significance level of the test was targeted at 0.05

Primary outcome:

Clinical pregnancy rate in endometriosis patients stage I and II undergoing endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month.

Secondary outcome:

Ovulation rate in endometriosis patients stage I and II undergoing endometriosis suppression with dienogest 2mg / day for 3 month followed by induction of ovulation for 3 month.

Inclusion criteria:

All women recruited in this study will have the have a definitive diagnosis of endometriosis grade I or grade II via laparoscopy just before randomization.

Method of Randomization:

A Computerized generated list from the internet https://www.sealedenvelope.com/sirnple-randomiser/vl/lists

Allocation concealment:

Closed envelope method by a nurse not participating in the study Intervention It is a prospective randomized controlled trial. Investigation done after recruitment and before randomization.

The patients will be randomized in to two groups:

Group A: patients receive dienogest 2 mg (visanne 2mg sanofi Aventis) daily for three months then followed by induction of ovulation with clomiphene citrate (clomid 5mg sanofi aventis for three months.

Group B: Patients will undergo induction of ovulation with clomiphene citrate (clomid 50mg sanofi aventis) for three months.

Protocol of induction of ovulation

  1. Clomiphen citrate (clomid 50mg sanofi aventis) will be given on day two of the menstrual cycle at a dose of 50 mg twice daily for five days.
  2. Folliculometry will be performed every other day starting from seventh day of the cycle till ovulation occurs using a 6 Mhz transvaginal probe till the follicles reach 18 - 20 mm.
  3. A trigger of ovulation HCG 10000iu is given IM when the follicles reach 18- 22 mm. The couple will be advised to have intercourse after 36 hrs then daily for 7 days.
  4. Prontogest 400 mg (progest 400 mg Sanofi Aventis) daily vaginal suppository as a luteal phase support.
  5. Pregnancy will be diagnosed quantitative B HCG blood test after 2 days missed period.
  6. Clinical pregnancy rate will be diagnosed by TVUS confirmed fetal echo with pulsation at 5-7 weeks gestation.

The sonographer confirming clinical pregnancy will be blinded to both groups. Statistical Analysis

Statistical Method:

Statistical analysis will be performed using Microsoft Excel version 2010 and statistical package for social sciences ( SPSS ) for windows version l S.O.

Continious data are to be presented as range, mean and standard deviation (if parametric); or range; median and inter quartile range (if non - parametric).

Dichotomous or categorical data are to be presented as number and percentage. Difference between independent is to be estimated using independent student's t-test (for parametric continuous variables), Manny whitney test U-test (for non -parametric continuous variables) and Chi-square and test (for categorical variables). Receiver operator characteristics curve is to be constructed to assess the predictability is to be expressed in terms of sensitivity , specificity , positive and negative predictive values. Significance level is at 0.05.

Ethical and legal aspects

Delegation of investigator responsibilities:

The investigator will ensure that all persons assisting with the trial are adequately informed about the protocol, any amendments to the protocol, the study treatments, and their trial-related duties and functions.

Patient information and informed consent:

Before being admitted to the clinical study, the patient must consent to participate after the nature, scope and possible consequences of the clinical study have been explained in a form understandable to her and a written consent will be obtained.

Confidentiality:

Only the patient initials will be recorded in the files, and if the patients name appears on any other document, it must be kept in a privacy by the investigators. The investigator will maintain a personal patient identification list (patient initials with the corresponding patient names) to enable records to be identified.

Protocol approval:

Before the beginning of the study and in accordance with the local regulation followed, the protocol and all the corresponding documents will be declared for Ethical and Research approval by the council of the obstetrics Department, Ain Shams University.

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: sherif Abdelhamid, professor
  • Phone Number: 01001424742

Study Contact Backup

  • Name: Noha rabei, professor
  • Phone Number: 01227174996

Study Locations

  • Egypt
    • C
      • Abbasia, C, Egypt
        • Recruiting
        • AinshamsU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. All women recruited in this study will have the have- a definitive diagnosis of endometriosis grade I or grade II via laparoscopy just before randomization.

Exclusion Criteria:

  1. Male factor.
  2. Other factors e.g. mullerian duct anomalies, hydrosalpinx.
  3. Age > 35 years.
  4. Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2
Drug: Dienogest 2mg
Dienogest 2mg is given daily for 3 months then followed by Clomiphene citrate 5 mg induction of ovulation for three months
Drug: Clomiphene citrate 5 mg
Clomiphene citrate 5 mg for induction of ovulation for three months
Active Comparator: group B
patients diagnosed laparoscopically with Endometriosis Stage 1 and Stage 2
Drug: Clomiphene citrate 5 mg
Clomiphene citrate 5 mg for induction of ovulation for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 2 months
fetal life detected by ultrasound
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: up to 21 days
ovulation rate is recorded before triggering
up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: laila fareed, lecturer, 01222148471
  • Study Director: mostafa fouad, professor, 01226188993

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

September 5, 2015

First Submitted That Met QC Criteria

October 11, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA000017585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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