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To test whether GnRHa withheld 2-3 days before ovulation trigger reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who have been treated with gonadotropins for in vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI).
All the patients received a midluteal long GnRH agonist (GnRH-a) and a gonadotropins (recombinant FSH) stimulation protocol. Pituitary down-regulation with GnRH agonist (triptorelin, 0.1mg/d, ×10d, then 0.05mg/d until E2 ≤40 pg/ml in serum), was initiated during the luteal phase on the cycle-day 21. Two weeks later, if E2 in serum was ≤40 pg/ml and absence of follicular activity was detected, the stimulation of ovaries was started by recombinant follicle-stimulating hormone (recFSH, Gonal-F, Serono, Switzerland) with doses ranging 150-250 IU/d. Doses were adjusted accordingly with ovarian monitoring and follicles growth. GnRHa (0.05mg/d) was injected stimulously with FSH before dominant follicles were ≥ 14 mm. When the diameter of one or more follicles was ≥ 14 mm, GnRHa (0.05mg/d) was withheld in the study group. In the control group, GnRHa was used to the day of ovulation trigger. Ovulation was induced with HCG (5000-10000 IU) when at least three follicles greater than 16mm in diameter were detected on ultrasound examination and the leading follicles reached ≥ 18 mm in diameter. Oocytes retrieval for IVF or ICSI was performed 34-36 hours later under transvaginal ultrasound guidance.
Main Outcome Measure(s): Serum E2 levels, VEGF levels in Serum and follicular fluids, retrieved oocytes, fertilization, implantation rate and pregnancy rate (PR), the rate of OHSS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH agonist withdrawal | Experimental | All the patients received a midluteal long GnRH agonist (GnRH-a) and a gonadotropins (recombinant FSH) stimulation protocol. When the diameter of one or more follicles was ≥ 14 mm, GnRHa (0.05mg/d) was withheld in the study group. |
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| control group | No Intervention | All the patients received a midluteal long GnRH agonist (GnRH-a) and a gonadotropins (recombinant FSH) stimulation protocol. In the control group, GnRHa (triptorelin, 0.05mg/d,)was used to the day of ovulation trigger. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a drug withdrawal during the long protocol | Drug | GnRHa (triptorelin,0.05mg/d) was injected stimulously with FSH before dominant follicles were ≥ 14 mm. When the diameter of one or more follicles was ≥ 14 mm, GnRHa (triptorelin,0.05mg/d) was withheld in the study group. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of ovarian hyperstimulation | Ovarian hyperstimulation syndrome is a complication from some forms of fertility medication. Most cases are mild, but a small proportion are severe. Symptoms are set into 3 categories: mild, moderate, and severe. | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate in the patients with IVF or ICSI | one month |
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Inclusion Criteria:
ninety-six infertile patients with PCOs (12 or more follicles 2-9 mm in diameter were detected in ovaries by ultrasound detection) undergoing IVF treatment were enrolled.
Exclusion Criteria:
the subjects included the followings: a basal FSH level of > 10IU/L; age >35 years; a body mass index (BMI) > 30 kg/m2; ovarian surgery radiotherapy or chemotherapy; ovarian dysfunction; endometriosis; hyperprolactinemia; thyroid dysfunction; the presence of organic pelvic diseases.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Wang, Master | Contact | 86-25-8310-7170 | wangbin_429@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Hai-xiang Sun, ph.D | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18706551 | Background | Ho Yuen B, Nguyen TA, Cheung AP, Leung PC. Clinical and endocrine response to the withdrawal of gonadotropin-releasing hormone agonists during prolonged coasting. Fertil Steril. 2009 Aug;92(2):499-507. doi: 10.1016/j.fertnstert.2008.06.039. Epub 2008 Aug 15. |
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