NCT05585177

Brief Summary

This study was a prospective randomized controlled trial. Patients aged \<35 years with decreased clinical reserve function (AFC\<5, Follicle stimulating hormone \> 10miu/ml, Anti-mullerian hormone \< 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

October 15, 2022

Last Update Submit

October 20, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of embryos

    When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.

    4 months

Secondary Outcomes (2)

  • The number of oocytes retrieved

    4 months

  • Clinical pregnancy rate

    5-8months

Study Arms (2)

Growth hormone pretreatment+IVF/ICSI

EXPERIMENTAL

After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed

Drug: Growth hormone

IVF/ICSI

NO INTERVENTION

IVF/ICSI was performed

Interventions

Growth hormoneDRUG

3 months of growth hormone treatment (2 units daily)

Also known as: IVF/ICSI
Growth hormone pretreatment+IVF/ICSI

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \< 35 years;
  • AFC≤5
  • Follicle stimulating hormone \> 10miu/ml;
  • Anti-mullerian hormone \< 1.1μg/L
  • (2 out of 2-4 items can be met)

You may not qualify if:

  • Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
  • Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
  • Diabetes mellitus, insulin resistance;
  • chromosomal karyotype abnormality in either spouse;
  • Any pregnancy or contraindications of assisted reproductive technology;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Haixiang Sun, PHD

    The affiliated Drum Towel Hospital of Nanjing University Medical School

    STUDY DIRECTOR

Central Study Contacts

Qingqing Shi, PHD

CONTACT

025-83106666qqshnju@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical Scho

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 18, 2022

Study Start

November 1, 2022

Primary Completion

November 30, 2024

Study Completion

October 30, 2025

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

CN(1)