Prolonged Protocol of Early Follicular or Mid Luteal Phase

NCT ID: NCT04522479

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2024-05-13

Brief Summary

Due to the injection of gonadotropin releasing hormone agonist (GnRH-a) before controlled ovarian hyperstimulation (COH), the scheme of prolonged early follicular period protocol has obvious advantages in achieving ideal egg number, increasing endometrial receptivity to embryo transfer, inhibiting endogenous luteinizing hormone (LH) peak and reducing cycle cancellation rate. The full dose of long acting GnRH-a was also applied before COH in the mid luteal Hypergrowth program, and the mechanism of its lowering tone was similar. But whether the clinical and perinatal outcome of early follicular hyperlengthening is as effective as that of mid luteal hyperlengthening has not been reported at home and abroad. Moreover, there is a lack of prospective randomized controlled studies.

Detailed Description

One injection of 3.75mg GnRHa was injected on the 1st-3rd or 21st-23rd day of menstruation. The level of estradiol (E2), progesterone (P), luteinizing hormone (LH) in peripheral blood and the number of follicles in bilateral ovarian internal sinuses were monitored on the 32nd-38th day after pituitary hyporegulation.Gonadotropin (Gn) will be given after pituitary desensitization. When the diameter of at least two follicles ≥ 18mm or more than three follicles ≥ 17mm, the trigger of human chorionic gonadotropin (hCG) will be given and oocyte will be retrieved. The selective fresh single blastocyst transplantation will be carried out on the 4th-6th day after oocyte retrieval. HCG test at 12nd day after transplatation. Follow-up investigation will given during the pregnancy and perinatal period.

Conditions

IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

prolonged protocol of early follicular phase

Inject a full dose of GnRH-a in 1st-3rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

prolonged protocol of middle luteal phase

Inject a full dose of GnRH-a in 21st-23rd day of menstruation (leuprorelin acetate, injection, 3.75mg), the level of E2, P, LH in peripheral blood and the number of follicles in bilateral internal ovarian sinuses were monitored 32-38 days after the depression. If the pituitary desensitization was achieved, Gn (recombinant human follicle stimulating hormone or urofollicle stimulating hormone, injection, 75-300iu) was used for contralled hyperstimulation, when the diameter of 2 follicles was ≥ 18mm，hCG (human chorionic gonadotropin, injection, 4000-10000IU) was used to trigger and retrieve the oocyte. Selective single blastocyst transplantation was performed on the 4th-6th day after the oocyte retrieved. β-hCG was detected on the 12th day after embryo transplantation, and pregnancy or not was judged. If patients get pregnancy, follow-up was continued until the 42nd day after baby delivery.

Group Type: EXPERIMENTAL

Change the injection time of long acting GnRH-a

Intervention Type: OTHER

The whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation

Interventions

Change the injection time of long acting GnRH-a

The whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Tubal factor infertility;

2. polycystic ovary (PCO) or polycystic ovary syndrome (PCOS) patients;

3. Patients of mild to moderate endometriosis；

4. Oligoasthenospermia in male；

5. More than 5 antral follicle count (AFC) on both ovaries；

6. Unexplained infertility: there is a history of no contraception and pregnancy for more than 1 year, no clear cause of infertility such as ovulation, fallopian tube, endometrium and male factors is found, or the above factors return to normal after treatment.

Exclusion Criteria

1. History of adverse pregnancy and childbirth；

2. Unilateral ovariectomy；

3. Uterine malformation, intrauterine adhesion, submucous myoma；

4. Chromosomal abnormality of both husband and wife；

5. Patients with contraindications of assisted reproductive technology or pregnancy: such as uncontrolled diabetes mellitus, undiagnosed liver and kidney dysfunction, history of deep vein thrombosis, history of pulmonary embolism, history of cerebrovascular accident, uncontrolled hypertension, heart disease, suspected cervical cancer, endometrial cancer, breast cancer or previous history, undetermined vaginal bleeding;

6. Unable to be regularly follow up；

7. Participating in other clinical trials；

8. No fresh single blastocyst transfer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingfen Ying

Role: PRINCIPAL_INVESTIGATOR

The 2nd Affiliated Hospital of Wenzhou Medical University

Locations

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingfen Ying

Role: CONTACT

1192108952@qq.com

+086-13732091230

Facility Contacts

Yingfen Ying

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SAHoWMU-CR2019-07-115

Identifier Type: -

Identifier Source: org_study_id