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Efficacy of polyethylene glycol recombinant human growth hormone on pregnancy outcomes for patients with thin endometrium undergoing frozen embryo transfer: a pilot study

Efficacy of polyethylene glycol recombinant human growth hormone on pregnancy outcomes for patients with thin endometrium undergoing frozen embryo transfer: a pilot study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073172
Enrollment
Unknown
Registered
2023-07-03
Start date
2023-07-10
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thin endometrium

Interventions

Intervention group:Pretreatment with long-acting growth hormone before FET
Control group:Routine HRT+FET

Sponsors

Renji Hospital Affiliated to Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 39 Years

Inclusion criteria

Inclusion criteria: (1) Females aged 20-39; (2) Endometrial thickness<7 mm in trigger day of conventional ovulation protocol or progestogen conversion day 2 or more times previously; (3) BMI: 18-30kg/m2 (included); (4) patients who will planing to perform freeze-thaw single blastocyst transplantation (including IVF, ICSI, and PGT-A cycles); (5) At least 1 blastocyst in IVF/ICSI cycles or at least 1 euploid embryo in PGT-A cycles left for transfer, with a Gardner morphological score of = 4BC (D5 or D6); (6) Be capable of giving informed consent.

Exclusion criteria

Exclusion criteria: (1) Existing uterine diseases that clearly affect the morphology of the uterine cavity or endometrial receptivity, such as Uterine malformation or abnormality (including mediastinal uterus, Unicornuate uterus, double uterus, uterine cavity adhesion), submucosal myoma, intramural myoma protruding into the uterine cavity, untreated hydrosalpinx, genital system tuberculosis, etc; (2) History of = 2 spontaneous abortions; (3) PGT cycles due to chromosomal abnormalities or monogenic diseases; (4) Contraindication of growth hormone, such as acute proliferative or severe nonproliferative diabetic retinopathy, severe systemic infection, potential tumor patients with any signs of progress and confirmed tumor patients (5) Severe acute and chronic liver and kidney diseases, such as cirrhosis, acute and chronic renal failure, hepatitis B virus active period, patients with abnormal liver and kidney function, the AST or ALT detection value is 2.5 times higher than the normal upper limit, and the blood creatinine is 2 times higher than the normal upper limit, etc; (6) History of immune system diseases, such as antiphospholipid syndrome, systemic lupus erythematosus, and rheumatism; (7) Patients with contraindication to assisted reproductive technology and/or pregnancy; (8) Those who have used growth hormone products within one month; (9) Engaging in other drug clinical research; (10) Those who are not suitable for participation due to other reasons

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
Chemical pregnancy rate;Clinical pregnancy rate;Pregnancy loss rate;Ectopic pregnancy rate;Endometrial Thickness on progestogen initiate day;Endometrial morphology on progestogen initiate day;Endometrial blood flow indicators on progestogen initiate day;

Countries

China

Contacts

Public ContactYun Sun

Renji Hospital Affiliated to Shanghai Jiao Tong University

syun163@163.com+86 136 0163 4278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026