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Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG
The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles > 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual trigger group | Active Comparator | Trigger with concomitant GnRHa and HCG (single low-dose) administration |
|
| Single low-dose HCG group | Active Comparator | Trigger with GnRHa then HCG (single low-dose) administration in luteal phase |
|
| Multiple low-doses HCG group | Active Comparator | Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRHa and HCG | Drug | Final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures | 6 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte maturation rate | Number of mature oocytes divided by the number of retrieved oocytes | On day of oocyte retrieval |
| Incidence of early OHSS | Incidence of OHSS within 9 days of final triggering of oocyte maturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed S Abdelhafez, Dr | Contact | +201144523366 | msabdelhafez@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed S Abdelhafez, Dr | Mansoura University | Principal Investigator |
| Waleed El-refaie, Dr | Port Said University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Care Unit (FCU) in Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D006063 | Chorionic Gonadotropin |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| GnRHa then HCG (single low-dose) | Drug | Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will be administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval) |
|
|
| GnRHa then HCG (multiple low-doses) | Drug | Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval |
|
|
| Within 9 days of final triggering of oocyte maturation |
| Implantation rate | Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos | 6 weeks after embryo transfer |
| Miscarriage rate | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies | 12 weeks gestational age |
| Private fertility care centers | Recruiting | Al Mansurah | Dakahlia Governorate | Egypt |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006062 | Gonadotropins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |