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

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ClinicalTrials.gov Identifier: NCT02575248
Recruitment Status : Unknown
Verified June 2017 by Alhassan Mohammad Khedr, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : October 14, 2015
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Alhassan Mohammad Khedr, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Dienogest 2mg Drug: Clomiphene citrate 5 mg Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 11 With and Without Suppression by Dienogest
Study Start Date : October 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 2 months ]
    fetal life detected by ultrasound


Secondary Outcome Measures :
  1. Ovulation rate [ Time Frame: up to 21 days ]
    ovulation rate is recorded before triggering



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575248


Contacts
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Contact: sherif Abdelhamid, professor 01001424742
Contact: Noha rabei, professor 01227174996

Locations
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Egypt
AinShamsU Recruiting
Abbasia, C, Egypt
Contact: alhassan mo khedr, Assistant lecture    01006193797    hasankhedr@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: laila fareed, lecturer 01222148471
Study Director: mostafa fouad, professor 01226188993

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Responsible Party: Alhassan Mohammad Khedr, principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT02575248     History of Changes
Other Study ID Numbers: fwa000017585
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by Alhassan Mohammad Khedr, Ain Shams University:
dienogest
infertility
endometriosis
Additional relevant MeSH terms:
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Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female
Dienogest
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Nandrolone
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Contraceptive Agents, Male
Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Antineoplastic Agents, Hormonal