Prolonged Protocol of Early Follicular or Mid Luteal Phase

NCT04522479 | Unknown DMC

• 1 other identifier: SAHoWMU-CR2019-07-115
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF

Keywords

prolonged protocol; In vitro fertilization (IVF); Intracytoplasmic sperm injection (ICSI); single blastocyst transfer

Outcome Measures

Primary Outcomes (1)

• live birth rate

  live birth rate per transplantation cycle

  live birth of more than 28 pregnancy weeks

Secondary Outcomes (5)

• clinical pregnancy rate

  fetal heart beat confirmed by transvaginal ultrasound 26-35 days after embryo transplantation

• good quality blastocyst rate

  The ratio of good quality blastocysts above 4BB degree 4-6 days after oocyte collection

• Incidence rate of early on-set severe ovarian hyperstimulation syndrome (OHSS)

  Severe ovarian hyperstimulation syndrome according to Golan standard within 7 days after ovum removal

• Early misscarage rate

  Abortion before 12 pregnancy weeks

• Perinatal complications

  Incidence rate of mother and child complications from pregnancy to postpartum in 42 days

Study Arms (2)

prolonged protocol of early follicular phase

NO INTERVENTION

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.

prolonged protocol of middle luteal phase

EXPERIMENTAL

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.

Other: Change the injection time of long acting GnRH-a

Interventions

Change the injection time of long acting GnRH-a OTHER

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

prolonged protocol of middle luteal phase

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Tubal factor infertility;
• polycystic ovary (PCO) or polycystic ovary syndrome (PCOS) patients;
• Patients of mild to moderate endometriosis；
• Oligoasthenospermia in male；
• More than 5 antral follicle count (AFC) on both ovaries；
• 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.

You may not qualify if:

• History of adverse pregnancy and childbirth；
• Unilateral ovariectomy；
• Uterine malformation, intrauterine adhesion, submucous myoma；
• Chromosomal abnormality of both husband and wife；
• 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;
• Unable to be regularly follow up；
• Participating in other clinical trials；
• No fresh single blastocyst transfer.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325027, China

RECRUITING

Study Officials

• Yingfen Ying

  The 2nd Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfen Ying

CONTACT

+086-13732091230; 1192108952@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statistician blindness
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The early follicular and mid luteal prolonged regimens were randomly enrolled in a ratio of 1 to 1

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 21, 2020
• Study Start: May 13, 2020
• Primary Completion: May 13, 2023
• Study Completion: May 13, 2024
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

CN (1)