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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Completed OBSERVATIONAL NCT03527823

The Comparison of Granulosa Cell Apoptosis Rates With or Without Luteinizing Hormone Administration in Poor Responders.

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

In Zeynep Kamil Women and Children's Education and Research Hospital which is a tertiary referral hospital, the investigators perform microdose flare-up gonadotropin-releasing hormone (GNRH) analogue or GNRH antagonist protocol to the poor responders. The investigators may or may not supplement luteinizing hormone (LH). Human chorionic gonadotropin (hCG) triggering is performed when at least 2 follicles diameter are above 17 mm and the serum estradiol level is above 500 pg / ml. 36 hours after hCG, ovarian aspiration is performed by the guidance of transvaginal ultrasound. Normally after oocyte separation process, the remaining follicle aspiration fluid is destroyed. n the present study, the follicle aspiration fluid is planned to be used with the patient's permission. The investigators are going to examine the granulosa cell apoptosis rate by using annexin-5 antibody in both groups 1 (LH added) and 2 (without LH). For this purpose, a total of 40 volunteer patients are planned to involve, the groups are designed as 20 LH added and 20 LH added women. In the present study, the investigators hypothesis that the rates of granulosa cell apoptosis in poor responders may be different between the group 1 (with LH) and group 2 (without LH), this will lead to IVF therapy in the near future.

Detailed Description

The supplementation of human menopausal gonadotropin (HMG) in terms of luteinizing hormone (LH) support in controlled ovarian stimulation (COS) is a controversial issue. Follicle stimulating hormone (FSH) and LH are required for ovarian steroidogenesis in anovulatory women with gonadotropin deficiency according to the two cell-two gonadotropin hypothesis. LH supplementation is needed to ensure adequate follicular estradiol (E2) production during the follicular phase, completion of oocyte maturation and development in the endometrium. Despite, the need for LH for ovarian stimulation in normogonadotropic women is controversial. Additional LH supplementation during stimulation with FSH may provide an advantage in increasing follicle development and thus may be shortening the duration of treatment. It has been suggested that the change of gonadotropins from FSH to LH in the presence of ovarian stimulation is beneficial in the development of a more homogeneous follicular cohort \[1\] \[2\]. However, contrary opinions have reported that LH supplementation does not bring any additional benefit \[3\]. In recent years, studies have been done to investigate the utility of the addition of LH as well as FSH to the cycle outcome. In a Cochrane review, the combination of recombinant follicle stimulating hormone (r-FSH) and recombinant luteinizing hormone (r-LH) administration in in vitro fertilization/intracytoplasmic sperm injection (IVF / ICSI) cycles compared to only r-FSH cycles in 14 randomized controlled trials \[4\]. When r-LH was added, there was no statistical difference in terms of pregnancy outcomes. However, due to the small size of the work, the net result was not achieved. The other study supported the treatment of rFSH alone, while the addition of r-LH was found to be beneficial only in one of the studies \[5, 6\] . As a result, there is no significant difference in live birth rates. However, the studies in only poor responders showed a significant increase in pregnancy rates with the addition of r-LH \[5, 7\]. In contrast, recently Bosch et al. reported that the addition of r-LH in the 36-39 age group of patients with GnRH antagonist protocol benefit from LH support, while patients under the age of 36 do not \[8\]. In conclusion, there is no consensus to administrate r-LH to the protocols of poor responders. Our hypothesis is LH administration may decrease granulosa apoptosis rate in follicular fluids and may be beneficial to poor responders and over age of 35. In Zeynep Kamil Women and Children's Education and Research Hospital where the data of study patients is going to be collected, the investigators are applying microdose flare-up GNRH analogue or GNRH antagonist protocol to the poor responders. The investigators may or may not supplement LH. hCG is performed when at least 2 follicles are 17 mm and the serum estradiol level is above 500 pg / ml. 36 hours after hCG, ovarian aspiration is performed by the guidance of transvaginal ultrasound. Normally after oocyte separation process, the remaining follicle aspiration fluid is destroyed. The follicle aspiration fluid is planned to be used within the permission of the patient in the present study. The investigators are going to examine the granulosa cell apoptosis rate with using annexin-5 antibody in group 1 (LH added) and group 2 (without LH). For this purpose, a total of 40 volunteer patients are planned to have 20 LH added and 20 LH added patient groups. Statistical analysis is going to be performed using SPSS 11 program. p \<0.05 will be considered significant. In the present study, the investigators hypothesis that comparing the rates of granulosa cell apoptosis in poor responders as two different groups (with and without addition of LH) will lead to IVF therapy in the near future.

Primary Outcomes

Measure: the comparison of granulosa cell apoptosis rate with or without LH supplementation in poor responders
TimeFrame: June 2018-August 2018
Description: the investigators hypothesized that granulosa cell apoptosis rate on luteinizing hormone supplemented microdose flare up GnRH analog protocol in poor ovarian responders undergoing in vitro fertilization would be lower than not administered protocol

Trial Information

NCT ID

NCT03527823

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Sebnem Alanya Tosun

Last Updated

December 15, 2025