An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients (LPS-IHH)
Primary Purpose
Luteal Phase Deficiency, Luteal Phase Support, Idiopathic Hypogonadotropic Hypogonadism
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Additional hCG injection
estrogen and dydrogesterone
Sponsored by
About this trial
This is an interventional treatment trial for Luteal Phase Deficiency focused on measuring Luteal phase deficiency, Idiopathic hypogonadotropic hypogonadism
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of IHH (primary amenorrhea (with or without a history of hormone supplementation therapy); basic LH levels <5IU/L, FSH<5IU/L or normal; no organic lesions in the hypothalamus and pituitary MRI).
- Women of childbearing age who desire to get pregnant
Exclusion Criteria:
- Premature ovarian insufficiency or premature ovarian failure
- Primary amenorrhea due to hypothalamic/pituitary lesions
- Secondary amenorrhea
Sites / Locations
- OB & GYN Hospital of Fudan UniversityRecruiting
- Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Additional hCG injection
No additional hCG injection
Arm Description
An additional hCG injection of 2000-5000IU would be performed 48 hours following routine hCG trigger on the basis of supplementation of estrogen and dydrogesterone in IHH patients.
Only estrogen and dydrogesterone would be given for luteal phase support in IHH patients.
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Defined as the presence of a gestational sac under ultrasonography
Cumulative pregnancy rate
Defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
Live birth rate
Defined as the number of deliveries that resulted in a live born neonate, expressed per 100 pregnancies.
Secondary Outcome Measures
Number of IHH patients ending in early pregnancy loss
Early pregnancy loss is defined as the loss of a pregnancy prior to 12 weeks gestation
Number of IHH patients with ovarian hyperstimulation syndrome
Ovarian hyperstimulation syndrome is defined as an exaggerated response to excess hormones. It usually occurs in women taking injectable hormone medications to stimulate the development of eggs in the ovaries. Ovarian hyperstimulation syndrome (OHSS) causes the ovaries to swell and become painful.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05569577
Brief Title
An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
Acronym
LPS-IHH
Official Title
An Open-labeled Prospective Randomized Controlled Trial on the Effect of Different Regimens for Luteal Phase Support on Pregnancy Outcomes in Patients With Idiopathic Hypogonadotropic Hypogonadism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for patients with idiopathic hypogonadotropic hypogonadism (IHH). Luteal phase support (LPS) is one of the indispensable interventions in ART treatments for IHH patients, which includes progestin, estrogen, human chorionic gonadotropin (hCG), and GnRH agonists (GnRHa). We aim to verify additional hCG injection 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone could improve clinical pregnancy rate, cumulative pregnancy rate, live birth rate and the prevalence of early pregnancy loss and ovarian hyperstimulation syndrome (OHSS) by an open labeled, prospective, and randomized clinical trial (RCT) in IHH patients in a single center.
Detailed Description
Idiopathic hypogonadotropic hypogonadism (IHH) is a congenital disease caused by a variety of gene variants leading to dysfunction in the secretion of hypothalamic gonadotropin-releasing hormones (GnRHs), with a prevalence of 1:125 000 in females. Girls with IHH often suffer from lack of puberty onset, amenorrhea and infertility, complicated with psychological problems such as depression and anxiety, due to delayed diagnosis and inappropriate treatment. Luteal phase deficiency (LPD) accounts for most failures of assistant artificial reproduction (ART) and early pregnancy loss for IHH patients. We have reported a severe LPD during the early trimester in a case with secondary HH following craniopharyngioma resection and speculated similar LPD happen in IHH patients complicated with low clinical pregnancy rate and live birth rate. Therefore, luteal phase support (LPS) is one of the indispensable interventions in ART treatments for IHH patients, which includes progestin, estrogen, human chorionic gonadotropin (hCG), and GnRH agonists (GnRHa). We aim to verify additional hCG injection 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone could improve clinical pregnancy rate, cumulative pregnancy rate, live birth rate and the prevalence of early pregnancy loss and ovarian hyperstimulation syndrome (OHSS) by an open labeled, prospective, and randomized clinical trial (RCT) in IHH patients in a single center of the Obstetrics and Gynecology Hospital Affiliated to Fudan University. The onset of patients' mental and psychological diseases such as depression and anxiety rely on their reproductive needs and pregnancy outcomes, which will also be investigated in the current study. Moreover, the effect of clinical interventions to improve pregnancy outcomes and emotional disorders would be discussed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Luteal Phase Deficiency, Luteal Phase Support, Idiopathic Hypogonadotropic Hypogonadism
Keywords
Luteal phase deficiency, Idiopathic hypogonadotropic hypogonadism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We have two cohorts in the current study and patients are randomly assigned to either cohort of additional hCG injection or not.
Masking
None (Open Label)
Masking Description
In the current study, none of patients, investigators and designers is marked.
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Additional hCG injection
Arm Type
Experimental
Arm Description
An additional hCG injection of 2000-5000IU would be performed 48 hours following routine hCG trigger on the basis of supplementation of estrogen and dydrogesterone in IHH patients.
Arm Title
No additional hCG injection
Arm Type
Placebo Comparator
Arm Description
Only estrogen and dydrogesterone would be given for luteal phase support in IHH patients.
Intervention Type
Drug
Intervention Name(s)
Additional hCG injection
Intervention Description
An additional hCG injection of 2000-5000IU would be given 48 hours following routine hCG trigger and ovulation for LPS on the basis of supplementation of estrogen and dydrogesterone.
Intervention Type
Drug
Intervention Name(s)
estrogen and dydrogesterone
Intervention Description
estrogen and dydrogesterone
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Defined as the presence of a gestational sac under ultrasonography
Time Frame
7 weeks
Title
Cumulative pregnancy rate
Description
Defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
Time Frame
12 weeks
Title
Live birth rate
Description
Defined as the number of deliveries that resulted in a live born neonate, expressed per 100 pregnancies.
Time Frame
42 weeks or beyond
Secondary Outcome Measure Information:
Title
Number of IHH patients ending in early pregnancy loss
Description
Early pregnancy loss is defined as the loss of a pregnancy prior to 12 weeks gestation
Time Frame
12 weeks
Title
Number of IHH patients with ovarian hyperstimulation syndrome
Description
Ovarian hyperstimulation syndrome is defined as an exaggerated response to excess hormones. It usually occurs in women taking injectable hormone medications to stimulate the development of eggs in the ovaries. Ovarian hyperstimulation syndrome (OHSS) causes the ovaries to swell and become painful.
Time Frame
12 weeks or beyond
Other Pre-specified Outcome Measures:
Title
Serum progesterone levels on Day 1, 7, and 14 after ovulation
Description
Serum progesterone levels is a symbol of luteal function
Time Frame
7 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women aged between 18-45 years is reproductive. IHH patients in the age have willings to get pregnant and they would seek helps in outpatient clinic of Gynecological endocrinology.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of IHH (primary amenorrhea (with or without a history of hormone supplementation therapy); basic LH levels <5IU/L, FSH<5IU/L or normal; no organic lesions in the hypothalamus and pituitary MRI).
Women of childbearing age who desire to get pregnant
Exclusion Criteria:
Premature ovarian insufficiency or premature ovarian failure
Primary amenorrhea due to hypothalamic/pituitary lesions
Secondary amenorrhea
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hexia Xia, M.D.
Phone
+86 13601843476
Email
hexia_xia@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, Ph.D.,M.D.
Phone
+86 13611691036
Email
zhangwei623@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Ph.D.,M.D.
Organizational Affiliation
GCP office
Official's Role
Principal Investigator
Facility Information:
Facility Name
OB & GYN Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hexia Xia, Doctor
Phone
13601843476
Email
hexia_xia@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Hexia Xia, Doctor
First Name & Middle Initial & Last Name & Degree
Haiyun Guan, Doctor
First Name & Middle Initial & Last Name & Degree
Rongmin Wang, Master
First Name & Middle Initial & Last Name & Degree
Zhijing Tang, PhD student
Facility Name
Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, PhD
Phone
+86 13611691036
Email
zhangwei623@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients
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