Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

NCT03300518 | Completed DMC

• 1 other identifier: MSD-MISP-ZX-01
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none pretreatment GnRH antagonist protocol for the number of oocytes retrieval

Conditions

Infertility

Keywords

GnRH antagonist; Estrogen pretreatment; Poor response patient

Outcome Measures

Primary Outcomes (1)

• The number of oocytes retrieved by the IVG 36 hours after hCG administration

  The total MII oocytes retrievedd

  36 hours after hCG administration

Secondary Outcomes (3)

• Clinical pregnancy rate

  6weeks

• ongoing pregnancy rate

  12weeks

• Optimal number of embryo

  1 week

Study Arms (2)

pretreatment group

OTHER

the pretreatment group underwent a modified treatment protocol with pretreatment with estogen administering during the cycle preceding the IVF/ICSI cycle. daily dose of 4 mg (2 mg twice a day) estradiol valerate was given orally in the middle luteal phase which is confirmed seven days after ovulation monitoring by the ultrasound up to 2 days of the next menstrual cycle.Recombinant FSH (Puregon) was initiated on menstrual cycle day 2- 3 at an initial dose of 300 IU/day.A daily administration of ganirelix (0.25 mg Orgalutran; Organon) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger.

Drug: Follitropin Beta;MSD; Drug: Ganirelix; Drug: hCG; Drug: estradiol valerate

control groups

OTHER

In the control groups standard GnRH-antagonist protocol was applied.Recombinant FSH (Puregon) was initiated on menstrual cycle day 2- 3 at an initial dose of 300 IU/day.A daily administration of ganirelix (0.25 mg Orgalutran; Organon) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger.

Drug: Follitropin Beta;MSD; Drug: Ganirelix; Drug: hCG

Interventions

Follitropin Beta;MSD DRUG

Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.

Also known as: Puregon

control groups; pretreatment group

Ganirelix DRUG

A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.

Also known as: Orgalutran

control groups; pretreatment group

hCG DRUG

Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger

Also known as: Ovidrel

control groups; pretreatment group

estradiol valerate DRUG

Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle

Also known as: progynova

pretreatment group

Eligibility Criteria

• Age: 40 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:
• Advanced maternal age (≥40 years) or any other risk factor for POR
• A previous POR (≤3 oocytes with a conventional stimulation protocol)
• An abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or AMH\< 0.5 - 1.1 ng/mL)

You may not qualify if:

• Age ≥45 years,
• Patients who conducted PGD/PGS, and donor egg cycles were excluded.
• Presence of unilateral ovary absence
• Abnormal uterine deformity or structure.
• Spontaneous abortion patients with three or more (including biochemical pregnancy abortion)
• With other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction
• Have assisted reproductive technology contraindications or pregnancy contraindication of patients

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Reproductive & Genetic Hospital of Citic-Xiangya

Changsha, Hunan, China

Location

Related Publications (1)

• Zhang S, Tang Y, Wang X, Zong Y, Li X, Cai S, Ma H, Guo H, Song J, Lin G, Lu G, Gong F. Estrogen valerate pretreatment with the antagonist protocol does not increase oocyte retrieval in patients with low ovarian response: a randomized controlled trial. Hum Reprod. 2022 Jun 30;37(7):1431-1439. doi: 10.1093/humrep/deac081.

  PMID: 35460400 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follitropin beta; ganirelix; Ovidrel; Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Fei Gong, Doctor

  Reproductive & Genetic Hospital of CITIC-Xiangya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: November 15, 2017
• Primary Completion: June 18, 2021
• Study Completion: August 18, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)