The Application of a New Ovarian Stimulation Protocol in IVF

August 20, 2018 updated by: Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

The Application of a New Ovarian Stimulation Protocol in IVF: a Randomized Controlled Study

Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly.

At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in around 85% patients in the investigator's center. However, patients have to inject short term GnRH-a 0.05mg or 0.1mg daily for around 3 weeks in one IVF cycle.

Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation.

The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary outcome is ongoing pregnancy rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Caihong Chen, M.D
  • Phone Number: 86-371-67967161
  • Email: reinbow@126.com

Study Contact Backup

  • Name: Zhiqin Bu, M.D
  • Phone Number: 86-371-67967167
  • Email: rmczzu@126.com

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
        • Contact:
          • Zhiqin Bu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • First IVF cycle;
  • With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
  • With normal uterine.

Exclusion Criteria:

  • Pre-implantation genetic diagnosis cycles;
  • Oocyte donation or sperm donation cycles.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: New protocol group
Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated.
Drug: GnRH-a
In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.
Drug: GnRH-a
In control group, patients use short term GnRH-a. Patients' serum or follicle fluid will be collected if needed.
ACTIVE_COMPARATOR: Standard GnRH-a long protocol
Use short GnRH-a 0.1mg at luteal phase of last menstrual cycle for 10 days and 0.05mg for another 4 days. Once pituitary down regulation is achieved,controlled ovarian hyperstimulation using gonadotropins is initiated. During ovarian stimulation, short GnRH-a is used daily at the dose of 0.05mg until human chorionic gonadotrophin (HCG) trigger.
Drug: GnRH-a
In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.
Drug: GnRH-a
In control group, patients use short term GnRH-a. Patients' serum or follicle fluid will be collected if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 12 weeks after embryo transfer
12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
12 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: 1 day at oocyte retrieved day
1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate
Time Frame: 48 hours after oocyte retrieved day
Number of 2PN/Matured oocytes
48 hours after oocyte retrieved day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Yingpu Sun, M.D, Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (ESTIMATE)

July 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMCZZU-New protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovulation Induction

Clinical Trials on GnRH-a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe