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Study of Effect of GnRHa Withdrawal at Late Stage of Long Protocol on the Risk of Ovarian Hyper-stimulation in Patients With Polycystic Ovary (PCO) Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles


N/A
23 Years
35 Years
Open (Enrolling)
Female
Infertile High-risk Patients With Polycystic Ovaries

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Trial Information

Study of Effect of GnRHa Withdrawal at Late Stage of Long Protocol on the Risk of Ovarian Hyper-stimulation in Patients With Polycystic Ovary (PCO) Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

incidence of ovarian hyperstimulation

Outcome Description:

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.

Outcome Time Frame:

two weeks

Safety Issue:

Yes

Principal Investigator

Hai-xiang Sun, ph.D

Investigator Role:

Study Director

Investigator Affiliation:

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Authority:

China: Ministry of Health

Study ID:

NJGLHRMCSUN1

NCT ID:

NCT01634724

Start Date:

July 2012

Completion Date:

June 2013

Related Keywords:

  • Infertile High-risk Patients With Polycystic Ovaries
  • GnRH agonist withdrawal
  • OHSS
  • E2
  • VEGF
  • Infertility
  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome

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