Tags

Type your tag names separated by a space and hit enter

Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial.
Hum Reprod. 2015 Oct; 30(10):2387-95.HR

Abstract

STUDY QUESTION

Can the luteal phase support be improved in terms of efficacy, hormonal profiles and convenience as compared with today's standard care?

SUMMARY ANSWER

Daily low-dose rhCG supplementation in GnRHa triggered IVF cycles can replace the traditional used luteal phase support with exogenous progesterone.

WHAT IS KNOWN ALREADY

A bolus of hCG for final maturation of follicles in connection with COS may induce the risk of OHSS and the luteal phase progesterone levels rise very abruptly in the early luteal phase.

STUDY DESIGN, SIZE, DURATION

This is a proof-of-concept study conducted as a three arm RCT with a total of 93 patients. First patient enrolled in January 2012 and the study finished in January 2014.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Normal responder women undergoing IVF/ICSI treatment in a university hospital. One arm served as control, where women followed a standard antagonist protocol. Two study arms were included both having 125 IU hCG daily for luteal phase support without exogenous progesterone after using a GnRHa trigger for ovulation induction. In both study arms exogenous FSH was stopped on stimulation day 6 and replaced by exogenous hCG that was initiated on either stimulation day 2 or day 6. Blood samples were obtained on the day of ovulation induction, on the day of oocyte pickup (OPU) and day OPU + 7.

MAIN RESULTS AND THE ROLE OF CHANCE

The mean serum levels of hCG did not exceeded the normal physiological range of LH activity in any samples. Mid-luteal progesterone levels were significantly higher in the two study groups receiving daily low-dose hCG for luteal phase support as compared with the control group (control group: 177 ± 27 nmol/l; study group 1: 334 ± 42 nmol/l; study group 2: 277 ± 27 nmol/l; (mean ± SEM). No differences in reproductive outcome were seen between groups.

LIMITATIONS, REASONS FOR CAUTION

The number of patients included is limited and conclusions need to be verified in a larger RCT.

WIDER IMPLICATIONS OF THE FINDINGS

Endogenous production of progesterone may become more attractive as the luteal phase support with levels of LH-like activity only in the physiological range and may, from the patients' point of view, replace inconvenient exogenous progesterone preparation. Further hCG may reduce the cost of stimulation and may collectively be used for stimulation of the follicular phase, ovulation induction and for luteal phase support.

STUDY FUNDING/COMPETING INTERESTS

An unrestricted grant from ARTS Biologics made this study possible. None of the authors has any competing interests to declare.

TRIAL REGISTRATION NUMBER

ClinicalTrial.gov number: NCT01504139.

TRIAL REGISTRATION DATE

28 December 2011.

Authors+Show Affiliations

Laboratory of Reproductive Biology, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Copenhagen, Denmark Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark yding@rh.dk.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.The Fertility Clinic, Skive Regional Hospital, Skive, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26209535

Citation

Andersen, Claus Yding, et al. "Daily Low-dose hCG Stimulation During the Luteal Phase Combined With GnRHa Triggered IVF Cycles Without Exogenous Progesterone: a Proof of Concept Trial." Human Reproduction (Oxford, England), vol. 30, no. 10, 2015, pp. 2387-95.
Andersen CY, Elbaek HO, Alsbjerg B, et al. Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial. Hum Reprod. 2015;30(10):2387-95.
Andersen, C. Y., Elbaek, H. O., Alsbjerg, B., Laursen, R. J., Povlsen, B. B., Thomsen, L., & Humaidan, P. (2015). Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial. Human Reproduction (Oxford, England), 30(10), 2387-95. https://doi.org/10.1093/humrep/dev184
Andersen CY, et al. Daily Low-dose hCG Stimulation During the Luteal Phase Combined With GnRHa Triggered IVF Cycles Without Exogenous Progesterone: a Proof of Concept Trial. Hum Reprod. 2015;30(10):2387-95. PubMed PMID: 26209535.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial. AU - Andersen,Claus Yding, AU - Elbaek,Helle Olesen, AU - Alsbjerg,Birgit, AU - Laursen,Rita Jakubcionyte, AU - Povlsen,Betina Boel, AU - Thomsen,Lise, AU - Humaidan,Peter, Y1 - 2015/07/23/ PY - 2015/05/21/received PY - 2015/07/01/accepted PY - 2015/7/26/entrez PY - 2015/7/26/pubmed PY - 2016/7/28/medline KW - GnRH antagonist KW - GnRHa trigger KW - IVF KW - IVF stimulation KW - hCG for follicular stimulation KW - low-dose hCG KW - luteal phase support SP - 2387 EP - 95 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 30 IS - 10 N2 - STUDY QUESTION: Can the luteal phase support be improved in terms of efficacy, hormonal profiles and convenience as compared with today's standard care? SUMMARY ANSWER: Daily low-dose rhCG supplementation in GnRHa triggered IVF cycles can replace the traditional used luteal phase support with exogenous progesterone. WHAT IS KNOWN ALREADY: A bolus of hCG for final maturation of follicles in connection with COS may induce the risk of OHSS and the luteal phase progesterone levels rise very abruptly in the early luteal phase. STUDY DESIGN, SIZE, DURATION: This is a proof-of-concept study conducted as a three arm RCT with a total of 93 patients. First patient enrolled in January 2012 and the study finished in January 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS: Normal responder women undergoing IVF/ICSI treatment in a university hospital. One arm served as control, where women followed a standard antagonist protocol. Two study arms were included both having 125 IU hCG daily for luteal phase support without exogenous progesterone after using a GnRHa trigger for ovulation induction. In both study arms exogenous FSH was stopped on stimulation day 6 and replaced by exogenous hCG that was initiated on either stimulation day 2 or day 6. Blood samples were obtained on the day of ovulation induction, on the day of oocyte pickup (OPU) and day OPU + 7. MAIN RESULTS AND THE ROLE OF CHANCE: The mean serum levels of hCG did not exceeded the normal physiological range of LH activity in any samples. Mid-luteal progesterone levels were significantly higher in the two study groups receiving daily low-dose hCG for luteal phase support as compared with the control group (control group: 177 ± 27 nmol/l; study group 1: 334 ± 42 nmol/l; study group 2: 277 ± 27 nmol/l; (mean ± SEM). No differences in reproductive outcome were seen between groups. LIMITATIONS, REASONS FOR CAUTION: The number of patients included is limited and conclusions need to be verified in a larger RCT. WIDER IMPLICATIONS OF THE FINDINGS: Endogenous production of progesterone may become more attractive as the luteal phase support with levels of LH-like activity only in the physiological range and may, from the patients' point of view, replace inconvenient exogenous progesterone preparation. Further hCG may reduce the cost of stimulation and may collectively be used for stimulation of the follicular phase, ovulation induction and for luteal phase support. STUDY FUNDING/COMPETING INTERESTS: An unrestricted grant from ARTS Biologics made this study possible. None of the authors has any competing interests to declare. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov number: NCT01504139. TRIAL REGISTRATION DATE: 28 December 2011. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/26209535/Daily_low_dose_hCG_stimulation_during_the_luteal_phase_combined_with_GnRHa_triggered_IVF_cycles_without_exogenous_progesterone:_a_proof_of_concept_trial_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dev184 DB - PRIME DP - Unbound Medicine ER -