OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol

Last updated: March 18, 2019
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT03881904
OCP-AntagonistPCOS
  • Ages 18-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-39 years of age.

  2. BMI 18-29 Kg/m2

  3. Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus ondiagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-SponsoredPCOS Consensus Workshop Group - by the presence of two of the following threediagnostic features:

  4. Oligo- or anovulation [defined as fewer than eight episodes of menstrual bleedingper year or menses that occur at intervals greater than 35 days].

  5. Clinical hyperandrogenism [defined by the presence of hirsutism (assessed by amodified Ferriman-Gallwey score ≥ 8), acne or androgenic alopecia] and/orbiochemical signs of hyperandrogenism [defined by elevated free androgen index]

  6. Polycystic ovaries [defined as presence of 12 or more follicles in each ovarymeasuring 2 - 9 mm in diameter, and/or increased ovarian volume > 10 mL) in theearly follicular phase (cycle days 3 - 5) in regularly menstruating women.Oligo-/amenorrhoeic women should be scanned either at random or between days 3and 5 after a progestin-induced withdrawal bleeding. This definition does notapply to women taking oral contraceptive pills, since their use modifies ovarianmorphology in normal women and putatively in women with PCO. After exclusion of other etiologies (congenital adrenal hyperplasia, androgensecreting tumors, Cushing's syndrome, hypothyroidism and hyperprolactinemia).

  7. Normal transvaginal ultrasonography apart from polycystic ovaries (see before).

  8. Normal office hysteroscopy.

  9. Normal hysterosalpingography.

  10. Absence of any structural pathological findings in laparoscopy apart from enlargedsclerotic polycystic ovaries.

  11. Normal hormonal profile (apart from hormonal abnormalities associated with PCOS), e.g.normal thyroid function tests

  12. Normal parameters of male semen analysis according to WHO criteria 2010.

  13. First trial IVF/ICSI.

  14. Written and signed informed consent by the patient to participate in the study.

Exclusion

Exclusion Criteria:

  1. Age more than 39 years.

  2. BMI more than 29 Kg/m2

  3. Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.

  4. Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia orfibroid.

  5. Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.

  6. Abnormal male or female karyotyping.

  7. Abnormal endocrinological profile during ovarian stimulation not attributed to PCOS,e.g. hypothyroidism, FSH > 12 mIU/mL on day 3.

  8. Previous trials of IVF/ICSI.

  9. Positive anticardiolipin antibodies or lupus anticoagulant.

  10. Positive thrombophilia screen.

  11. Abnormal semen analysis parameters according to WHO criteria 2010.

  12. Any hormonal treatment within the last 3 months.

  13. Any treatment for insulin resistance within the last 3 months, e.g. metformin orleptin.

  14. Any chronic medical disorder, e.g. hypertension, autoimmune disorders, … etc.

  15. Any category 4 medical condition that contraindicates the usage of OCP according tothe WHO Medical eligibility criteria, 2015:

  • Smoking with age ≥ 35 years and cigarettes ≥ 15 /day.

  • Hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg).

  • Hypertension with vascular disease.

  • Previous history or acute DVT/PE.

  • Any known thrombogenic mutations.

  • Complicated valvular heart disease.

  • Systemic lupus erythematosus with positive or unkown antiphospholipid antibodies.

  • Migraine with aura.

  • Diabetes with nephropathy/neuropathy/retinopathy.

  • Diabetes > 20 years.

  • Acute hepatitis, severe cirrhosis or liver tumors.

  1. Mental condition rendering the patients unable to understand the nature, scope andpossible consequences of the study.

Study Design

Total Participants: 740
Study Start date:
June 01, 2017
Estimated Completion Date:
July 01, 2019

Study Description

The study will include 740 women with polycystic ovary syndrome undergoing IVF/ICSI cycle using flexible antagonist protocol.

Randomization:

Patients fulfilling the inclusion criteria will be randomized to two groups.

Study Group:

This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.

Control Group:

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.

Random allocation sequence generation:

A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups.

Allocation Concealment:

Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.

IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups.

Primary outcome will be ongoing pregnancy rate.

Secondary outcomes will be biochemical and clinical pregnancy rates.

Connect with a study center

  • AinShams Maternity Hospital

    Cairo, 002
    Egypt

    Active - Recruiting

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