Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

NCT ID: NCT03966339

Last Updated: 2022-01-11

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-12-31

Brief Summary

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GH plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.In this study, a prospective randomized control was used to explore the effect of GH adjuvant therapy on embryo quality.

Detailed Description

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Conditions

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Infertility,Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GH group

Growth Hormone adding to controlled ovarian hyperstimulation

Group Type EXPERIMENTAL

Growth hormone

Intervention Type DRUG

GH has been considered as a cogonadotropin, which plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.

control group

regular controlled ovarian hyperstimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Growth hormone

GH has been considered as a cogonadotropin, which plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.

Intervention Type DRUG

Other Intervention Names

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Experimental group

Eligibility Criteria

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Inclusion Criteria

* 1)infertility women whose age ≥20 and ≤39 years old; 2)women has done IVF/ICSI assisted treatment ≥1 times; 3)number of IVF/ICSI assisted treatment cylces with ≥6 oocytes retrieved ≥1; 4)number of IVF/ICSI assisted treatment cylces with ≥50% fertilization rate ≥1 ; 5)historical assisted reproduction cycles without ≥6C-Ⅱ level embryos at the third day after oocytes retrieval or without blastocyst formation after blastocyst culturing.

Exclusion Criteria

\- 1) Diseases related to IVF treatment outcome, such as untreated hydrosalpinx, uterine fibroids affecting uterine cavity, myometriosis, endometrial lesions, obvious uterine abnormalities,etc; 2)Severe acute or chronic liver or kidney diseases, such as cirrhosis, acute or chronic renal failure, hepatitis B virus activity period,etc.;in patients with abnormal liver and kidney function, the AST or ALT detection value was 2.5 times higher than the upper limit of normal, and the serum creatinine was 2 times higher than the upper limit of normal.

3)Endocrine and metabolic diseases and adrenal diseases, such as diabetes, Cushing's syndrome,etc.; 4)People has allergy history of growth hormone product; 5)Participating in other clinical research; 6)Other conditions that researchers determined not fit to be enrolled.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fei Gong, Doctor

Role: STUDY_DIRECTOR

Reproductive & Genetic Hospital of CITIC-Xiangya

Locations

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Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Tang, Doctor

Role: CONTACT

0731-82355100

Facility Contacts

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yi tang, doctor

Role: primary

0731-82355100

References

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Tang Y, Li X, Hu C, Guan R, Wang Z, Zhang S, Tao G, Qu J, Gong F. Exploring the potential benefits of growth hormone co-treatment on embryo quality in IVF: a randomized controlled open-label trial. Reprod Biol Endocrinol. 2025 Mar 15;23(1):42. doi: 10.1186/s12958-025-01374-3.

Reference Type DERIVED
PMID: 40089744 (View on PubMed)

Other Identifiers

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P2019004

Identifier Type: -

Identifier Source: org_study_id

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