OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol
Oral Contraceptive Pill Pretreatment in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Using the Gonadotrophin Releasing Hormone Antagonist Protocol (A Randomized Controlled Trial)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Khaled Afifi, MSc
- 電話番号:01009981222
- メール:DrKhaledAfifi@hotmail.com
研究場所
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Cairo、エジプト、002
- 募集
- AinShams Maternity Hospital
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コンタクト:
- Khaled Afifi, MSc
- 電話番号:01009981222
- メール:DrKhaledAfifi@hotmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
After exclusion of other etiologies (congenital adrenal hyperplasia, androgen secreting tumors, Cushing's syndrome, hypothyroidism and hyperprolactinemia).
- 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.
Exclusion Criteria:
- 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:
- 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.
- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:OCP Group
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.
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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.
他の名前:
|
介入なし: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Ongoing pregnancy rate
時間枠:20 gestational weeks
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Number of pregnancies completing ≥20 weeks gestational age expressed per 100 embryo transfer cycles
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20 gestational weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Chemical pregnancy rate
時間枠:6 gestational weeks
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Number of biochemical pregnancies (evidenced by positive pregnancy test in serum or urine without ultrasound evidence of a gestational sac) expressed per 100 embryo transfer cycles
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6 gestational weeks
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Clinical pregnancy rate
時間枠:6 gestational weeks
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Number of clinical pregnancies (evidenced by ultrasound visualization of a gestational sac and embryonic pole with heartbeat) expressed per 100 embryo transfer cycles
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6 gestational weeks
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Live birth rate
時間枠:38 gestational weeks
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The number of deliveries (> 28 weeks GA) that resulted in a live born neonate, expressed per 100 embryo transfers
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38 gestational weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mostafa Fouad, MD、Assistant Professor
- スタディディレクター:Ahmed Abbas, MD、lecturer
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OCP-AntagonistPCOS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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