Prolonged Protocol of Early Follicular or Mid Luteal Phase

IVF Clinical Trial

Official title:

Comparison of Efficacy and Safety of Controlled Hyperstimulation of Prolonged Protocol in Early Follicular or Mid Luteal Phase: a Single Center, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522479
• Other study ID #: SAHoWMU-CR2019-07-115
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: May 13, 2024

Study information

• Verified date: August 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Yingfen Ying
• Phone: +086-13732091230
• Email: 1192108952[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF

Intervention

Other:
• 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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	live birth rate per transplantation cycle	live birth of more than 28 pregnancy weeks
Secondary	clinical pregnancy rate	fetal heart beat confirmed by transvaginal ultrasound	fetal heart beat confirmed by transvaginal ultrasound 26-35 days after embryo transplantation
Secondary	good quality blastocyst rate	formation rate of more than 4BB Blastocyst	The ratio of good quality blastocysts above 4BB degree 4-6 days after oocyte collection
Secondary	Incidence rate of early on-set severe ovarian hyperstimulation syndrome (OHSS)	Severe ovarian hyperstimulation syndrome according to Golan standard	Severe ovarian hyperstimulation syndrome according to Golan standard within 7 days after ovum removal
Secondary	Early misscarage rate	Transvaginal sonography identified patients with abortion after clinical pregnancy	Abortion before 12 pregnancy weeks
Secondary	Perinatal complications	Perinatal complications of mothers and fetus	Incidence rate of mother and child complications from pregnancy to postpartum in 42 days