Evidence map›Paper›PMID 35964041›Full record

ArticleTrials2022

A novel GnRH antagonist protocol based on LH levels versus traditional flexible GnRH antagonist protocol in PCOS patients undergoing in vitro fertilization: study protocol for a randomized controlled, non-inferiority trial.

Shan Liu, Ya-Su Lv, Shuo Han, Minghui Liu, Shuai Ma, Haiying Ren, Yuan Li

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Shan LiuMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Ya-Su LvMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Shuo HanMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Minghui LiuMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Shuai MaMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Haiying RenMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Yuan LiMedical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. cyliyuan@126.com.ORCID http://orcid.org/0000-0002-1683-6801
Capital Medical University · CN

Funding

Beijing Health Promotion Foundation 2019-09-05Beijing Hospitals Authority Youth Programme QML20200301Capital Health Development Scientific Research Project Independent Innovation, 2020-1-2039
6 · The paper itself

Abstract

backgroundThe gonadotropin-releasing hormone (GnRH) antagonist protocol is advantageous given that it can avoid severe ovarian hyperstimulation syndrome (OHSS), especially for patients with polycystic ovary syndrome (PCOS). Basic and clinical evidence has shown that a threshold of luteinizing hormone (LH) stimulation is required for adequate follicular development and oocyte maturation. Ultra-low or high levels of LH are detrimental to pregnancy outcomes. We previously demonstrated that LH could be an indicator for the timing and dosage of antagonist administration in a retrospective study. METHODS/

designIn this randomized, single-center, non-inferiority trial, we aim to test the hypothesis that there is no significant difference in cumulative ongoing pregnancy rates between PCOS patients stimulated with LH-based flexible protocol versus traditional flexible GnRH antagonist protocol. The primary efficacy endpoint will be the cumulative ongoing pregnancy rate per cycle. The secondary outcomes will be clinical pregnancy rate, cancelation rate, serious OHSS rate, and cost-efficiency. The cumulative ongoing pregnancy rate per cycle in PCOS women was 80%. Considering that a non-inferiority threshold should retain 80% of the clinical effect of a control treatment, a minimal clinical difference of 16% (two-sided: α, 2.5%; β, 20%) and a total of 196 patients were needed. Anticipating a 10% dropout rate, the total number of patients required was 216. DISCUSSION: The results of this study will provide evidence for the efficacy and safety of the LH-based flexible GnRH antagonist protocol in PCOS patients. Moreover, it evaluates the cost-efficiency of both protocols.

trial registrationChinese Clinical Trial Registry ChiCTR1800018129. Date assigned: 31 August 2018. PROTOCOL VERSION: 1.0 (18 July 2017).

Indexed as

Ovarian Hyperstimulation SyndromePolycystic Ovary SyndromeEquivalence Trials as TopicFemaleFertilization in VitroGonadotropin-Releasing HormoneHormone AntagonistsHumansLuteinizing HormoneOvulation InductionPregnancyRandomized Controlled Trials as TopicRetrospective StudiesGonadotropin-Releasing HormoneHormone AntagonistsLuteinizing HormoneEffectivenessGnRH antagonist protocolIVFLHPCOS

Identifiers

PMID35964041
PMCPMC9375259
OpenAlexW4291190236

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.