GnRH Agonist (GnRHa) Withdrawal at Late Stage of Long Protocol and the Incidence of Ovarian Hyper-stimulation

Infertile High-risk Patients With Polycystic Ovaries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01634724
• Other study ID #: NJGLHRMCSUN1
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2012
• Last updated: July 7, 2012
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Nanjing University
• Contact: Bin Wang, Master
• Phone: 86-25-8310-7170
• Email: wangbin_429[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Infertile High-risk Patients With Polycystic Ovaries
• Ovarian Hyperstimulation Syndrome
• Polycystic Ovary Syndrome

Intervention

Drug:
• a drug withdrawal during the long protocol
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.

Locations

Country	Name	City	State
China	Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital	Nanjing city	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	pregnancy rate in the patients with IVF or ICSI		one month	No