OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol

NCT03881904 | Unknown Phase 1 DMC

• 1 other identifier: OCP-AntagonistPCOS
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

Brief Summary

373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH. Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment. Both groups will be followed up for effect on ongoing pregnancy rate.

Conditions

Subfertility, Female

Keywords

PCOS; Anatgonist protocol; OCP pretreatment

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Number of pregnancies completing ≥20 weeks gestational age expressed per 100 embryo transfer cycles

  20 gestational weeks

Secondary Outcomes (3)

• Chemical pregnancy rate

  6 gestational weeks

• Clinical pregnancy rate

  6 gestational weeks

• Live birth rate

  38 gestational weeks

Study Arms (2)

OCP Group

ACTIVE COMPARATOR

This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive 0.075mg gestodene/0.03mg ethinylestradiol (Gynera®, Bayer Schering Pharma AG, Germany) from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.

Drug: 0.075mg gestodene/0.03mg ethinylestradiol

Control Group

NO INTERVENTION

This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment.

Interventions

0.075mg gestodene/0.03mg ethinylestradiol DRUG

OCPs will be started from day 2 of the cycle preceding COH and continued for 21 days, then induction of ovulation using antagonist protocol will be started.

Also known as: Gynera®

OCP Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-39 years of age.
• BMI 18-29 Kg/m2
• Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus on diagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group - by the presence of two of the following three diagnostic features:
• Oligo- or anovulation \[defined as fewer than eight episodes of menstrual bleeding per year or menses that occur at intervals greater than 35 days\].
• Clinical hyperandrogenism \[defined by the presence of hirsutism (assessed by a modified Ferriman-Gallwey score ≥ 8), acne or androgenic alopecia\] and/or biochemical signs of hyperandrogenism \[defined by elevated free androgen index\]
• Polycystic ovaries \[defined as presence of 12 or more follicles in each ovary measuring 2 - 9 mm in diameter, and/or increased ovarian volume \> 10 mL) in the early follicular phase (cycle days 3 - 5) in regularly menstruating women. Oligo-/amenorrhoeic women should be scanned either at random or between days 3 and 5 after a progestin-induced withdrawal bleeding. This definition does not apply to women taking oral contraceptive pills, since their use modifies ovarian morphology in normal women and putatively in women with PCO.
• Normal transvaginal ultrasonography apart from polycystic ovaries (see before).
• Normal office hysteroscopy.
• Normal hysterosalpingography.
• Absence of any structural pathological findings in laparoscopy apart from enlarged sclerotic polycystic ovaries.
• Normal hormonal profile (apart from hormonal abnormalities associated with PCOS), e.g. normal thyroid function tests
• Normal parameters of male semen analysis according to WHO criteria 2010.
• First trial IVF/ICSI.
• Written and signed informed consent by the patient to participate in the study.

You may not qualify if:

• Age more than 39 years.
• BMI more than 29 Kg/m2
• Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
• Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia or fibroid.
• Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
• Abnormal male or female karyotyping.
• Abnormal endocrinological profile during ovarian stimulation not attributed to PCOS, e.g. hypothyroidism, FSH \> 12 mIU/mL on day 3.
• Previous trials of IVF/ICSI.
• Positive anticardiolipin antibodies or lupus anticoagulant.
• Positive thrombophilia screen.
• Abnormal semen analysis parameters according to WHO criteria 2010.
• Any hormonal treatment within the last 3 months.
• Any treatment for insulin resistance within the last 3 months, e.g. metformin or leptin.
• Any chronic medical disorder, e.g. hypertension, autoimmune disorders, … etc.
• Any category 4 medical condition that contraindicates the usage of OCP according to the WHO Medical eligibility criteria, 2015:

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams Maternity Hospital

Cairo, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Mostafa Fouad, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Ahmed Abbas, MD

  Lecturer

  STUDY DIRECTOR

Central Study Contacts

Khaled Afifi, MSc

CONTACT

01009981222; DrKhaledAfifi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of O&G

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: June 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)