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Trial record 84 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Miniflare Versus Long Protocol in Poor Responders

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ClinicalTrials.gov Identifier: NCT02681536
Recruitment Status : Unknown
Verified March 2016 by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt.
Recruitment status was:  Recruiting
First Posted : February 12, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Brief Summary:
The study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing IVF/ICSI.

Condition or disease Intervention/treatment Phase
Infertility Drug: Triptorelin Drug: Combined oral contraceptive pills Drug: HMG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : February 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Minidose long protocol
Down-regulation started on day 20 of the previous cycle by GnRH agonist triptorelin (0.5 µg Decapeptyl; Ferring). On the second day of menstruation, when down regulation was confirmed (as evidenced by endometrial thickness <5 mm and/or E2 levels <50 pg/mL) using transvaginal sonography (TVS) by Voluson 730 Pro (GE, Fairfield, CT) apparatus, gonadotropin (Merional; IBSA) was commenced at an initial dose of 300-450 IU/day for the first 5 days followed by individual adjustment in Gn dose according to ovarian response and the dose of Decapeptyl 50µg/day was continued until day of HCG administration.
Drug: Triptorelin
Other Name: Decapeptyl

Drug: HMG
Other Name: merional

Experimental: microdose flare protocol
OCPs drospirenone /ethinyl estradiol (Yasmin, BAYER) for not less than 21 days before starting ovarian stimulation, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by HMG IM daily (Merional, 75 IU, IBSA) 3 days later. Then the same cycle adjustment was done as the minidose long protocol.
Drug: Triptorelin
Other Name: Decapeptyl

Drug: Combined oral contraceptive pills
Other Name: Yasmin

Drug: HMG
Other Name: merional




Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • poor responder women who fulfilled the criteria defined by the ESHRE consensus in 2011[4]; Poor responder females are those who possess two out of these three criteria: i) Female age ≥40 years; ii) Females who have at least one previous cancelled IVF cycle; iii) POR according to AFC ≤5 or low AMH value.

Exclusion Criteria:

  • females with FSH more than 20 IU/L
  • females with previous ovarian surgery
  • females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome
  • females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid
  • patients with male factor of infertility.

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): NCT02681536


Contacts
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Contact: Dina MR Dakhly, MD 01003498919 ext 002 dinadakhly@gmail.com

Locations
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Egypt
Kasr el aini hospital Recruiting
Cairo, Egypt, 12211
Contact: Dina M Dakhly, MD    01003498919 ext 002    Dinadakhly@gmail.com   
Principal Investigator: Dina M Dakhly, MD         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Dina MR Dakhly, MD Cairo University

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Responsible Party: Dina Mohamed Refaat Dakhly, Lecturer of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02681536     History of Changes
Other Study ID Numbers: FS090216
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Luteolytic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents