Verified May 2017 by Manh Tuong Ho, Vietnam National University
Mỹ Đức Hospital
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University
First received: May 30, 2017
Last updated: May 30, 2017
Last verified: May 2017
Until now very little information exists regarding the early luteal serum progesterone profile after Human chorionic gonadotropin (hCG) trigger. This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
|Progesterone||Other: Blood collection|
|Study Design:||Intervention Model: Single Group Assignment
Intervention Model Description:
IVF patients triggered with hCG
Masking: No masking
|Official Title:||The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG|
|Anticipated Study Start Date:||June 7, 2017|
|Estimated Study Completion Date:||April 1, 2018|
|Estimated Primary Completion Date:||August 1, 2017 (Final data collection date for primary outcome measure)|
Blood samples are collected for analysis of LH, E2, hCG and progesterone.
|Other: Blood collection
A total of ten (10) blood samples (2ml/each) will be collected during the study.
Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.
The early luteal phase after IVF treatment is only scarcely studied (Ragni et al., 2001; Fauser et al., 2002; Beckers et al., 2003, Humaidan et al., 2012). During IVF treatment the early luteinizing hormone (LH) activity deficit induced after ovarian stimulation with exogenous gonadotropins will be partly covered by the bolus of hCG used for triggering of final oocyte maturation due to the long half-life of hCG (Weissman et al., 1996; Fauser et al., 2002; Andersen C.Y and Vilbour Andersen, 2014). In addition, the luteal phase will be covered by exogenous progesterone supplementation. After successful implantation the embryo itself will provide the supportive LH activity, securing the function of the corpora lutea. However, during early luteal phase and peri-implantation recent data suggest that an early-mid-luteal hCG/LH deficiency exists after hCG trigger during which the corpus luteum lacks an optimal stimulation (Andersen CY and Vilbour Andersen, 2014). Furthermore, the early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial we wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.
|Ages Eligible for Study:||18 Years to 38 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Freeze all cycle after hCG trigger
- Age 18 – 38
- BMI < 28kg/m2
- Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
- Receiving gonadotrophin releasing hormone (GnRH) antagonist co-treatment during ovarian stimulation
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
- Previous poor response (≤ 3 oocytes) after high dose follicle stimulating hormone (FSH) stimulation
- Hyper-response defined as >20 follicles ≥ 14 mm
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03174691
Vietnam National University
Mỹ Đức Hospital
|Responsible Party:||Manh Tuong Ho, Doctor, Vietnam National University|
|ClinicalTrials.gov Identifier:||NCT03174691 History of Changes|
|Other Study ID Numbers:||VietnamNU|
|Study First Received:||May 30, 2017|
|Last Updated:||May 30, 2017|
|Individual Participant Data|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
ClinicalTrials.gov processed this record on June 02, 2017