MedDataX Logo

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

NCT ID: NCT01634724

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertile High-risk Patients With Polycystic Ovaries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

GnRH agonist withdrawal OHSS E2 VEGF

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GnRH agonist withdrawal

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.

Group Type EXPERIMENTAL

a drug withdrawal during the long protocol

Intervention Type 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.

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GnRH agonist wihtholding or GnRH agonist coasting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

23 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Li-jun Ding

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hai-xiang Sun, ph.D

Role: STUDY_DIRECTOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bin Wang, Master

Role: CONTACT

Phone: 86-25-8310-7170

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bin Wang, Master

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18706551 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NJGLHRMCSUN1

Identifier Type: -

Identifier Source: org_study_id