Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation

NCT03238833 | Completed DMC

• 1 other identifier: VGHKS15-CT11-12
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators attempted to compare the clinical outcomes and cumulus genes expression in poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian stimulation in in vitro fertilization cycles.

Conditions

Fertilization in Vitro

Keywords

In vitro fertilization; Poor ovarian responder; Luteal ovarian stimulation; Antagonist protocol; Cumulus cells

Outcome Measures

Primary Outcomes (1)

• oocytes and embryos

  retrieved oocytes in number, matured oocytes in number, fertilized oocytes in number, day 3 embryos in number, top-quality day 3 embryos in number

  through study completion, an average of 1 year

Secondary Outcomes (2)

• pregnancy rate

  Pregnancy will be confirmed 4 weeks after embryo transfer.

• genes expression

  through study completion, an average of 1 year

Study Arms (2)

luteal ovarian stimulation

EXPERIMENTAL

The controlled ovarian stimulation in in vitro fertilization cycle was started since luteal phase.

Other: luteal ovarian stimulation

follicular ovarian stimulation

ACTIVE COMPARATOR

The controlled ovarian stimulation in in vitro fertilization cycle was started since early follicular phase phase.

Other: follicular ovarian stimulation

Interventions

luteal ovarian stimulation OTHER

In the in vitro fertilization cycle, controlled ovarian stimulation was started since the luteal phase.

luteal ovarian stimulation

follicular ovarian stimulation OTHER

In the in vitro fertilization cycle, controlled ovarian stimulation was started since the follicular phase.

follicular ovarian stimulation

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Poor ovarian responders (PORs) met the Bologna criteria, having at least two of the three following features:
• advanced maternal age (≥ 40 years) or any other risk factor for POR,
• a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and
• an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle count (AFC) \< 5 or anti-Müllerian hormone (AMH) \< 1 ng/mL in this study.
• Moreover, two episodes of a previous POR after maximal stimulation alone would be sufficient to define a patient as a POR.

You may not qualify if:

• oophorectomy
• exposure to cytotoxic or pelvic irradiation for malignancy
• taking herbal drugs or other hormonal agents

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Related Publications (14)

• Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.

  PMID: 12849812 BACKGROUND

• Baerwald AR, Adams GP, Pierson RA. Ovarian antral folliculogenesis during the human menstrual cycle: a review. Hum Reprod Update. 2012 Jan-Feb;18(1):73-91. doi: 10.1093/humupd/dmr039. Epub 2011 Nov 8.

  PMID: 22068695 BACKGROUND

• Bedoschi GM, de Albuquerque FO, Ferriani RA, Navarro PA. Ovarian stimulation during the luteal phase for fertility preservation of cancer patients: case reports and review of the literature. J Assist Reprod Genet. 2010 Aug;27(8):491-4. doi: 10.1007/s10815-010-9429-0. Epub 2010 May 9.

  PMID: 20455017 RESULT

• von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-1365. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.

  PMID: 18930226 RESULT

• Maman E, Meirow D, Brengauz M, Raanani H, Dor J, Hourvitz A. Luteal phase oocyte retrieval and in vitro maturation is an optional procedure for urgent fertility preservation. Fertil Steril. 2011 Jan;95(1):64-7. doi: 10.1016/j.fertnstert.2010.06.064. Epub 2010 Aug 5.

  PMID: 20688325 RESULT

• Cakmak H, Rosen MP. Ovarian stimulation in cancer patients. Fertil Steril. 2013 May;99(6):1476-84. doi: 10.1016/j.fertnstert.2013.03.029.

  PMID: 23635348 RESULT

• Cakmak H, Katz A, Cedars MI, Rosen MP. Effective method for emergency fertility preservation: random-start controlled ovarian stimulation. Fertil Steril. 2013 Dec;100(6):1673-80. doi: 10.1016/j.fertnstert.2013.07.1992. Epub 2013 Aug 26.

  PMID: 23987516 RESULT

• Kuang Y, Hong Q, Chen Q, Lyu Q, Ai A, Fu Y, Shoham Z. Luteal-phase ovarian stimulation is feasible for producing competent oocytes in women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, with optimal pregnancy outcomes in frozen-thawed embryo transfer cycles. Fertil Steril. 2014 Jan;101(1):105-11. doi: 10.1016/j.fertnstert.2013.09.007. Epub 2013 Oct 23.

  PMID: 24161646 RESULT

• Martinez F, Clua E, Devesa M, Rodriguez I, Arroyo G, Gonzalez C, Sole M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.

  PMID: 25154677 RESULT

• Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6.

  PMID: 25444501 RESULT

• Li Y, Yang W, Chen X, Li L, Zhang Q, Yang D. Comparison between follicular stimulation and luteal stimulation protocols with clomiphene and HMG in women with poor ovarian response. Gynecol Endocrinol. 2016;32(1):74-7. doi: 10.3109/09513590.2015.1081683. Epub 2015 Sep 15.

  PMID: 26370530 RESULT

• Wei LH, Ma WH, Tang N, Wei JH. Luteal-phase ovarian stimulation is a feasible method for poor ovarian responders undergoing in vitro fertilization/intracytoplasmic sperm injection-embryo transfer treatment compared to a GnRH antagonist protocol: A retrospective study. Taiwan J Obstet Gynecol. 2016 Feb;55(1):50-4. doi: 10.1016/j.tjog.2015.07.001.

  PMID: 26927248 RESULT

• Chen YC, Li JY, Li CJ, Tsui KH, Wang PH, Wen ZH, Lin LT. Luteal Phase Ovarian Stimulation versus Follicular Phase Ovarian Stimulation results in different Human Cumulus cell genes expression: A pilot study. Int J Med Sci. 2021 Feb 4;18(7):1600-1608. doi: 10.7150/ijms.55955. eCollection 2021.

  PMID: 33746576 DERIVED

• Lin LT, Vitale SG, Chen SN, Wen ZH, Tsai HW, Chern CU, Tsui KH. Luteal Phase Ovarian Stimulation May Improve Oocyte Retrieval and Oocyte Quality in Poor Ovarian Responders Undergoing In Vitro Fertilization: Preliminary Results from a Single-Center Prospective Pilot Study. Adv Ther. 2018 Jun;35(6):847-856. doi: 10.1007/s12325-018-0713-1. Epub 2018 Jun 4.

  PMID: 29869107 DERIVED

Study Officials

• Kuan-Hao Tsui, PhD

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

• Salvatore Giovanni Vitale, M.D.

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 3, 2017
• Study Start: May 3, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)