Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response

NCT02940535 | Unknown DMC

• 1 other identifier: SW001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.

Conditions

Subfertility, Female; Ovulation Disorder

Outcome Measures

Primary Outcomes (1)

• live birth

  The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).

  3 years

Secondary Outcomes (1)

• clinical pregnancy rate

  3 years

Other Outcomes (10)

• multiple pregnancy

  3 years

• miscarriage

  3 years

• Ectopic pregnancy

  3 years

Study Arms (2)

Low Dose GnRHa

EXPERIMENTAL

Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28.

Drug: Diphereline (Triptorelin embonate); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin

GnRHa Ultra-short Protocol

ACTIVE COMPARATOR

Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2.

Drug: Decapeptyl (Triptorelin); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin

Interventions

Diphereline (Triptorelin embonate) DRUG

Low Dose GnRHa

Decapeptyl (Triptorelin) DRUG

GnRHa Ultra-short Protocol

human menopausal gonadotropin DRUG

GnRHa Ultra-short Protocol; Low Dose GnRHa

human chorionic gonadotropin DRUG

GnRHa Ultra-short Protocol; Low Dose GnRHa

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

You may not qualify if:

• Contraindications for IVF/ICSI
• Contraindications for pregnancy
• Primary ovarian insufficiency
• AFC \<3
• PGD/PGS

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Related Publications (1)

• Siristatidis CS, Yong LN, Maheshwari A, Ray Chaudhuri Bhatta S. Gonadotropin-releasing hormone agonist protocols for pituitary suppression in assisted reproduction. Cochrane Database Syst Rev. 2025 Jan 9;1(1):CD006919. doi: 10.1002/14651858.CD006919.pub5.

  PMID: 39783453 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Triptorelin Pamoate; Menotropins; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins, Pituitary; Gonadotropins; Pituitary Hormones, Anterior; Pituitary Hormones; Biological Products; Complex Mixtures; Placental Hormones; Pregnancy Proteins

Study Officials

• Wei Shang, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Yunhai Chuai, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Mingming Shu, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Ming Zhou, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Huiming Han, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Mengnan Chen, Dr

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Lei Chen

  Navy General Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Shang, Dr

CONTACT

shang.wei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: October 21, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)